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Scalp Block Versus Scalp Infiltration With Dexmedetomidine and Local Anesthetic for Post Craniotomy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02866409
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
Postgraduate Institute of Medical Education and Research, Chandigarh
Information provided by (Responsible Party):
NAVNEH SAMAGH, Postgraduate Institute of Medical Education and Research

Brief Summary:
This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control post craniotomy pain.A third group where patients were administered bupivacaine only infiltration has also been created.

Condition or disease Intervention/treatment Phase
Headache Procedure: scalp block Procedure: infiltration Drug: Dexmedetomidine Drug: Bupivacaine Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Post Craniotomy Pain
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupivacaine,dexmedetomidine scalp block
Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept < 2 mg /kg for scalp block
Procedure: scalp block

In this group following nerves were blocked-

  1. Supra-orbital nerve
  2. Supra-trochlear nerve
  3. Zygomatico-temporal nerve
  4. Auriculo-temporal nerve
  5. Posterior auricular branches of the greater auricular Nerve
  6. The greater, lesser, and third occipital nerves

Drug: Dexmedetomidine
Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.
Other Names:
  • Precedex
  • Dexdor

Drug: Bupivacaine
20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcain

Active Comparator: bupivacaine dexmedetomidine infiltration
The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.
Procedure: infiltration
The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.

Drug: Dexmedetomidine
Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.
Other Names:
  • Precedex
  • Dexdor

Drug: Bupivacaine
20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcain

Active Comparator: bupivacaine infiltration
The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.
Procedure: infiltration
The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.

Drug: Bupivacaine
20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcain




Primary Outcome Measures :
  1. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: Immediately after extubation ]
    Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain

  2. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 30 minutes after extubation ]
  3. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 1 hour after extubation ]
  4. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 1.5 hours after extubation ]
  5. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 2 hours after extubation ]
  6. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 4 hours post extubation ]
  7. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 8 hours post extubation ]
  8. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 12 hours post extubation ]
  9. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 16 hours post extubation ]
  10. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 20 hours post extubation ]
  11. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 24 hours post extubation ]
  12. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 36 hours post extubation ]
  13. post craniotomy pain by Numerical rating scale (NRS) [ Time Frame: 48 hours post extubation ]

Secondary Outcome Measures :
  1. chronic pain using Numerical rating scale (NRS) [ Time Frame: 1 month ]
    Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain

  2. chronic pain using Numerical rating scale (NRS) [ Time Frame: 3 months ]
  3. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 15 minutes interval till 2hrs post extubation and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  4. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 4 hours ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  5. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 8 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  6. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 12 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  7. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 16 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  8. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 20 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  9. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 24 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  10. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 36 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  11. post operative sedation using Modified Ramsay Sedation Scale [ Time Frame: 48 hours. ]

    Sedation Score-- by Modified Ramsay Sedation Scale

    1. Anxious/ Agitated/ Restless
    2. Cooperative/ Oriented/ Tranquil
    3. Responds to verbal commands
    4. Brisk response to light glabellar tap or loud noise
    5. Sluggish response to light glabellar tap or loud noise
    6. No Response

  12. rescue analgesic requirement in grams [ Time Frame: 24 hrs ]
    total rescue analgesic requirement in grams of paracetamol consumed in 24 hours

  13. rescue analgesic requirement in grams [ Time Frame: 48 hrs ]
    total rescue analgesic requirement in grams of paracetamol consumed in 48 hours


Other Outcome Measures:
  1. heart rate in beats per minute(bpm) [ Time Frame: 15 minutes interval till 2hrs ]
    15 minutes interval till 2hrs post extubation

  2. heart rate in beats per minute(bpm) [ Time Frame: 4 hours. ]
  3. heart rate in beats per minute(bpm) [ Time Frame: 8 hours. ]
  4. heart rate in beats per minute(bpm) [ Time Frame: 12 hours. ]
  5. heart rate in beats per minute(bpm) [ Time Frame: 16 hours. ]
  6. heart rate in beats per minute(bpm) [ Time Frame: 20 hours. ]
  7. heart rate in beats per minute(bpm) [ Time Frame: 24 hours. ]
  8. heart rate in beats per minute(bpm) [ Time Frame: 36 hours. ]
  9. heart rate in beats per minute(bpm) [ Time Frame: 48 hours. ]
  10. systolic blood pressure in mm of Hg [ Time Frame: 15 minutes interval till 2hrs ]
    15 minutes interval till 2hrs post extubation

  11. systolic blood pressure in mm of Hg [ Time Frame: 4 hours. ]
  12. systolic blood pressure in mm of Hg [ Time Frame: 8 hours. ]
  13. systolic blood pressure in mm of Hg [ Time Frame: 12 hours. ]
  14. systolic blood pressure in mm of Hg [ Time Frame: 16 hours. ]
  15. systolic blood pressure in mm of Hg [ Time Frame: 20 hours. ]
  16. systolic blood pressure in mm of Hg [ Time Frame: 24 hours. ]
  17. systolic blood pressure in mm of Hg [ Time Frame: 36 hours. ]
  18. systolic blood pressure in mm of Hg [ Time Frame: 48 hours. ]
  19. Diastolic blood pressure in mm of Hg [ Time Frame: 15 minutes interval till 2hrs ]
    15 minutes interval till 2hrs post extubation

  20. Diastolic blood pressure in mm of Hg [ Time Frame: 4 hours. ]
  21. Diastolic blood pressure in mm of Hg [ Time Frame: 8 hours. ]
  22. Diastolic blood pressure in mm of Hg [ Time Frame: 12 hours. ]
  23. Diastolic blood pressure in mm of Hg [ Time Frame: 16 hours. ]
  24. Diastolic blood pressure in mm of Hg [ Time Frame: 20 hours. ]
  25. Diastolic blood pressure in mm of Hg [ Time Frame: 24 hours. ]
  26. Diastolic blood pressure in mm of Hg [ Time Frame: 36 hours. ]
  27. Diastolic blood pressure in mm of Hg [ Time Frame: 48 hours. ]
  28. SpO2 in percentage [ Time Frame: 15 minutes interval till 2hours. ]
  29. SpO2 in percentage [ Time Frame: 4 hours. ]
  30. SpO2 in percentage [ Time Frame: 8 hours. ]
  31. SpO2 in percentage [ Time Frame: 12 hours. ]
  32. SpO2 in percentage [ Time Frame: 16 hours. ]
  33. SpO2 in percentage [ Time Frame: 20 hours. ]
  34. SpO2 in percentage [ Time Frame: 24 hours. ]
  35. SpO2 in percentage [ Time Frame: 36 hours. ]
  36. SpO2 in percentage [ Time Frame: 48 hours. ]
  37. respiratory rate in breaths per minute [ Time Frame: 15 minutes interval till 2hrs ]
    respiratory rate in breaths per minute at 15 minutes interval till 2hrs in post operative period after extubation

  38. respiratory rate in breaths per minute [ Time Frame: 4 hours. ]
  39. Respiratory rate in breaths per minute [ Time Frame: 8 hours. ]
  40. Respiratory rate in breaths per minute [ Time Frame: 12 hours. ]
  41. Respiratory rate in breaths per minute [ Time Frame: 16 hours. ]
  42. Respiratory rate in breaths per minute [ Time Frame: 20 hours. ]
  43. Respiratory rate in breaths per minute [ Time Frame: 24 hours. ]
  44. Respiratory rate in breaths per minute [ Time Frame: 36 hours. ]
  45. Respiratory rate in breaths per minute [ Time Frame: 48 hours. ]
  46. cognitive function using Modified self-devised questionnaire of short orientation memory concentration [ Time Frame: 30 minutes ]

    Modified self-devised questionnaire of short orientation memory concentration test

    1. What date is it today?
    2. What is the current year?
    3. What is his/her birthday?
    4. Count numbers 1 to 10.
    5. Count reverse numbers from 10 to 1.

  47. cognitive function using Modified self-devised questionnaire of short orientation memory concentration [ Time Frame: 60 minutes ]

    Modified self-devised questionnaire of short orientation memory concentration test

    1. What date is it today?
    2. What is the current year?
    3. What is his/her birthday?
    4. Count numbers 1 to 10.
    5. Count reverse numbers from 10 to 1.

  48. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 15 minutes interval till 2hrs ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  49. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 4 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  50. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 8 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  51. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 12 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  52. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 16 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  53. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 20 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  54. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 24 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  55. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 36 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.

  56. post operative nausea vomiting using Postoperative Nausea and Vomiting Scale [ Time Frame: 48 hours. ]

    Postoperative Nausea and Vomiting Scale

    1. No PONV: Absence of any emesis or nausea.
    2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.
    3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.
    4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neurosurgical patients
  • 18-70 years of age
  • ASA class I and II
  • Patients undergoing elective craniotomy, who were conscious and oriented to time, person and place and able to understand and use Numerical Rating Scale (NRS)

Exclusion Criteria:

  • Patient dull and irritable
  • GCS <15
  • Craniotomy incision extending beyond scalp (the field of the block) e.g. craniofacial surgery
  • Patients treated chronically with analgesics or narcotic medications
  • Allergy to local anaesthetics or dexmedetomedine
  • Patients planned for post-operative mechanical ventilation

Following patients were excluded from the study during collection of data in the postoperative period:-

  • Patients developing fever (≥39°C) in the postoperative period
  • Requiring postoperative ventilation (unplanned)
  • Having poor cognitive function at 1 hour postoperative period
  • GCS <15 in post-operative period.

Layout table for additonal information
Responsible Party: NAVNEH SAMAGH, senior resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02866409     History of Changes
Other Study ID Numbers: NK/1062/MD/13422-423
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by NAVNEH SAMAGH, Postgraduate Institute of Medical Education and Research:
dexmedetomidine
nerve block
anesthesia infiltration

Additional relevant MeSH terms:
Layout table for MeSH terms
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action