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Analgesic Efficacy of Ropivacaine Alone or in Combination With Adjuvants on Post-operative Analgesia Following Video-Assisted Thoracoscopic Surgery.

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ClinicalTrials.gov Identifier: NCT03809442
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Muhammad Saad Yousuf, Aga Khan University

Brief Summary:
The aim of the study is to investigate the analgesic effects of the subcutaneous wound infiltration with tramadol, ketamine, dexamethasone, dexmedetomidine and midazolam as adjuvant to ropivacaine, compared to ropivacaine alone in patients undergoing Video-Assisted thoracoscopic Surgery (VATS) procedures.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Drug: Ropivacaine + Ketamine Drug: Ropivacaine + Tramadol Drug: Ropivacaine + Midazolam Drug: Ropivacaine + Dexmedetomidine Drug: Ropivacaine + Dexamethasone Drug: Ropivacaine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Ropivacaine Alone or in Combination With Adjuvants on Post-operative Analgesia Following Video-Assisted Thoracoscopic Surgery (VATS) - A Randomized Controlled Trial.
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ropivacaine with Ketamine

Ropivacaine is a propyl analog of bupivacaine with longer duration of action with much safer cardiotoxicity profile than bupivacaine. Ropivacaine has the same analgesic effects as bupivacaine and levobupivacaine, but it is associated with a low incidence of motor block. Thus, ropivacaine appears to be an important component for local anesthesia and postoperative analgesia.

Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist that possesses both central and peripheral analgesic effects. Preincisional infiltration of ketamine prolongs the time to first analgesic requirement and also decreases the total amount of analgesics used postoperatively.

Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 1mg/kg ketamine (8 mL per incision) (ketamine group).

Drug: Ropivacaine + Ketamine
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 1mg/kg ketamine (8 mL per incision) (ketamine group).

Experimental: Ropivacaine with Tramadol

Tramadol hydrochloride is a synthetic analog of codeine that acts on both opioid (weak mu receptor agonist) and nonopioid receptors (inhibits reuptake of nor-adrenaline and serotonin as well as release stored serotonin from nerve endings) which play a crucial role in pain inhibition pathway.

It also blocks nerve conduction which imparts its local anesthetics like action on peripheral nerves.

In one study it was found that the addition of tramadol or midazolam to caudal epidural ropivacaine prolongs the duration of analgesia without causing significant side effects.

Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 2mg/kg tramadol (8 mL per incision) (Tramadol group).

Drug: Ropivacaine + Tramadol
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 2mg/kg tramadol (8 mL per incision) (Tramadol group).

Experimental: Ropivacaine with Midazolam

The analgesic effect of extradurally administered midazolam is through γ-amino butyric acid (GABA)/benzodiazepine system of spinal cord.

Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 50 μg/kg midazolam (8 mL per incision) (Midazolam group).

Drug: Ropivacaine + Midazolam
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 50 μg/kg midazolam (8 mL per incision) (Midazolam group).

Experimental: Ropivacaine with Dexamethasone

The glucocorticoid dexamethasone appears to be effective in a small number of preclinical and clinical studies and found that dexamethasone prolongs analgesia from interscalene blocks using ropivacaine or bupivacaine, with the effect being stronger with ropivacaine.

Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine+ 8mg dexamethasone (8 mL per incision) (Dexamethasone group).

Drug: Ropivacaine + Dexamethasone
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine+ 8mg dexamethasone (8 mL per incision) (Dexamethasone group).

Experimental: Ropivacaine with Dexmedetomidine

Dexmedetomidine is a new highly selective alpha2 (a2) agonist with known sedative, antihypertensive, anxiolytic, and analgesic properties.

In one study, it was found that wound infiltration with combined ropivacaine and dexmedetomidine found to be significantly superior for postoperative analgesia compared with either combined ropivacaine and tramadol or ropivacaine alone for lumbar discectomies.

Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% Ropivacaine + 0.5μg/kgdexmedetomidine (8mL per incision) (Dexmedetomidine group).

Drug: Ropivacaine + Dexmedetomidine
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% Ropivacaine + 0.5μg/kg dexmedetomidine (8mL per incision) (Dexmedetomidine group).

Placebo Comparator: Ropivacaine

Ropivacaine is a propyl analog of bupivacaine with longer duration of action with much safer cardiotoxicity profile than bupivacaine. Ropivacaine has the same analgesic effects as bupivacaine and levobupivacaine, but it is associated with a low incidence of motor block. Thus, ropivacaine appears to be an important component for local anesthesia and postoperative analgesia.

Patients will receive subcutaneous wound infiltration with 24ml of 0.25% Ropivacaine in three divided doses (i.e. 8 mL per incision) (control group). Total dose of Ropivacaine will be 60 mg.

Drug: Ropivacaine
Patients will receive subcutaneous wound infiltration with 24ml of 0.25% Ropivacaine in three divided doses (i.e. 8 mL per incision) (control group). Total dose of Ropivacaine will be 60 mg.




Primary Outcome Measures :
  1. Time to the first postoperative analgesia requirement [ Time Frame: Follow till 24 hours postoperatively ]
    Time to the first analgesic requirement will be calculated as the time from the performance of local wound infiltration to the first analgesic dose administered. This time will be noted in minutes.

  2. Visual analogue scale (VAS) [ Time Frame: Follow till 24 hours postoperatively ]

    Assessement for Postoperative Pain.

    The requirement of postoperative analgesia of the patient will be evaluated by using Visual analogue scale (VAS). It scored from 0 to 10 (where 0 [minimum score] = no pain and 10 [maximum score] = worst pain). Aggregate score will be added.

    Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. This score is just a numerical number with no other value attached to it.



Secondary Outcome Measures :
  1. Sedation using Pasero Opioid-Induced Sedation Scale (POSS) [ Time Frame: Follow till 24 hours postoperatively ]

    Sedation will be assessed by using Pasero Opioid-Induced Sedation Scale (POSS).

    This scale measures sedation on numerical score of 0 to 4. Minimum score is 0 while maximum score is 4.

    It comprises of; 0: awake; 1: mild sedation; 2: sleeping, but able to wake; 3: Frequently drowsy, arousable, drifts off to sleep during conversation, unable to wake and 4: Somnolent, minimal or no response to verbal or physical stimulation.

    A POSS score of 0, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation and the need for a reversal agent.

    This score is just a numerical number with no other value attached to it.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA I to III.
  2. Age >18 years.
  3. Either sex.
  4. Elective Video assisted thoracotomy surgery (VATS) under general anaesthesia

Exclusion Criteria:

  1. ASA IV & V.
  2. Coagulation disorders.
  3. Infection at the vicinity of the surgical wound.
  4. Raised intracranial pressure.
  5. History of hypersensitivity or known allergy to any study drug.
  6. History of opioid addiction.
  7. History of seizure disorder.
  8. Those who are not willing to participate in the study.
  9. Allergy to local anesthetics.
  10. Duration of surgery greater than 2 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809442


Contacts
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Contact: Muhammad Saad Yousuf, FCPS 9221+3003540362 ext 2898 saad.yousuf@aku.edu
Contact: Hameed Ullah, FCPS 9221+3332313134 ext 2898 hameed.ullah@aku.edu

Locations
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Pakistan
Aga Khan University Hospital Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Muhammad Saad Yousuf, FCPS    00923003540362 ext 2898    saad.yousuf@aku.edu   
Sponsors and Collaborators
Aga Khan University

Publications:
Bafna U, Sharma G, Sapru S, et al. Comparison of clonidine anddexmedetomidine as an adjuvant to 0.5% ropivacaine in supraclavicularbrachial plexus block: a prospective, randomized,doubleblindand controlled study. J Recent Adv Pain. 2015;1:73-77.

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Responsible Party: Dr. Muhammad Saad Yousuf, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT03809442     History of Changes
Other Study ID Numbers: 0743
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Midazolam
Dexmedetomidine
Ketamine
Tramadol
Ropivacaine
BB 1101
Analgesics
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
Hypnotics and Sedatives