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Dexamethasone & Bupivacaine vs Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Perioperative Analgesia in Patients Undergoing Lower Limb Surgeries

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ClinicalTrials.gov Identifier: NCT02576782
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Sherif Mohamed Abd el moneim Soaida, MD, Cairo University

Brief Summary:

In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks.

Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications.

The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of:

  • Onset of sensory blockade and motor blockade
  • Duration of analgesia / first request for analgesic
  • Duration of motor blockade

Condition or disease Intervention/treatment Phase
Pain Drug: Perineural Dexamethasone and bupivacaine Drug: Systemic Dexamethasone plus perineural bupivacaine Drug: intravenous saline plus perineural bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries
Study Start Date : June 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


Arm Intervention/treatment
Active Comparator: perineural dexamethasone group
21 patients received perineural dexamethasone plus bupivacaine 0.5%
Drug: Perineural Dexamethasone and bupivacaine
Active Comparator: systemic dexamethasone group
21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5%
Drug: Systemic Dexamethasone plus perineural bupivacaine
Sham Comparator: control group
21 patients received only perineural bupivacaine 0.5% plus intravenous saline
Drug: intravenous saline plus perineural bupivacaine



Primary Outcome Measures :
  1. Time of onset of sensory blockade [ Time Frame: upto 30 min ]
    from time of performing the nerve block till the occurrence of sensory block

  2. Time of onset of motor blockade [ Time Frame: up to 30 min ]
    from time of performing the nerve block till the occurrence of motor block

  3. Duration of analgesia [ Time Frame: upto 24 hours ]
    time from onset of analgesia till the first request for an analgesic

  4. Duration of motor blockade [ Time Frame: upto 24 hours ]
    time from motor blockade till ability to move the limb


Secondary Outcome Measures :
  1. perioperative hemodynamics [ Time Frame: time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval) ]
    systolic and diastolic blood pressure, heart rate before starting the procedure;Respiratory rate;and Oxygen saturation during the procedure and in the 24 hours following the procedure



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

Inclusion Criteria:

  • Age ranging from 18 to 70 years
  • American Society of Anesthesiologists (ASA) physical status I, II and III
  • Patients scheduled for lower limb vascular surgeries

Exclusion Criteria:

  • Patient refusal for the procedure
  • Any bleeding disorder or patients on anticoagulant therapy
  • Neurological deficits involving lumbar or sacral plexuses
  • Patients with allergy to local anaesthetics
  • Local infection at the injection site
  • Patients on any sedative or antipsychotic drugs
  • Body mass index > 35
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Responsible Party: Sherif Mohamed Abd el moneim Soaida, MD, Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02576782    
Other Study ID Numbers: SMS2015-1
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015
Keywords provided by Sherif Mohamed Abd el moneim Soaida, MD, Cairo University:
regional anesthesia
dexamethasone
bupivacaine
femoral
sciatic
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents