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Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on Post-operative Opioi

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT03372486
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
4.2
Actual Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effective post-operative pain control can reduce patient morbidity and affect the patient outcome. Brachial plexus block is one of them, a popular and widely employed regional nerve block technique for perioperative anesthesia and analgesia for surgery of the upper extremity.

Different drugs have been used as adjuvants with local anesthetics in brachial plexus block to achieve quick, dense and prolonged block like Morphine, Pethidine, Clonidine, Dexmedetomidine.

Naloxone is opioid antagonists which could selectively block the excitatory effects of opioids. it release endorphins and also displace endorphins from receptor site .it also reduce the opioid induced side effects, such as vomiting, nausea, pruritus, and respiratory depression.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

The aim of this study is to evaluate the effect of ultra-low dose of naloxone when added to bupivacaine %.05 in supraclavicular brachial plexus block in orthopedic upper limb surgery and if it enhances the anti-nociceptive effect of post-operative opioid

Effect of naloxone on anti-nociceptive criteria of post -operative opioid will be estimated by detecting the interval between each analgesic dose of post-operative opioid.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on the Anti-nociceptive Criteria of Post-operative Opioid in Orthopedic Upper Limb Surgeries
Actual Study Start Date :
Dec 18, 2017
Actual Primary Completion Date :
Apr 10, 2018
Actual Study Completion Date :
Apr 25, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivacaine plus naloxone

Patients will receive brachial plexus block using bupivacaine plus naloxone.

Drug: Bupivacaine plus naloxone
Patients received 20 mL bupivacaine 0.5% plus 100 ng naloxone (1ml) in 2ml saline.(naloxone ampoule 0.4mg will dilute in 400ml of saline then 1ml of it will dilute in 10 ml saline, so each ml will have 100ng naloxone)
Placebo Comparator: Bupivacaine

Patients will receive brachial plexus block using bupivacaine.

Drug: Bupivacaine
Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline

Outcome Measures

Primary Outcome Measures

  1. Effect of ultra-low dose naloxone on the post operative opioid [for 48 hours after surgery]

    by estimate the analgesic requirements of opioids and the interval between each opioid dose in 48 hour post operative

Secondary Outcome Measures

  1. Duration of sensory block [For 48 hours after surgery]

    will be defined as the time interval between the complete sensory block (complete absence of pinprick response) and first experience with postoperative pain

  2. Duration of motor block [For 48 hours after surgery]

    defined as the time interval between complete paralysis (Lovett rating scale = 0) and complete recovery (Lovett rating scale = 6)

  3. Onset time of sensory block [For 48 hours after surgery]

    defined as the time between the end of the last injection and complete absence of pinprick response in all nerve distribution

  4. Onset time of motor block [For 48 hours after surgery]

    defined as the time between the end of the last injection and complete paralysis (Lovett rating scale = 0) in all nerve distributions

  5. Severity of post-operative pain [For 48 hours after surgery]

    will be measured by visual analogue scale (VAS) where 0 was equal to no pain and 10 indicated the worst possible pain

  6. 1st time of analgesic request [For 48 hours after surgery]

    First need for rescue opioid after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • American Society of Anesthesiology (ASA) physical state class Ι and II

  • Elective upper limb orthopedic surgery (hand, forearm and elbow)

  • Duration of surgery ≤180 min

  • BMI ≤30 kg/m2

Exclusion Criteria:

  • History of allergy to the drug of the study.

  • Coagulation disorders

  • Infection at the puncture site.

  • Pregnancy

  • Opioid abuse.

  • Abuse of tranquilizers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University, Central Hospital, emergency Unit Mansourah Dakahlia Egypt 050

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Doaa G Diab, MD, Assistant Professor of Anesthesia and Surgical Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT03372486
Other Study ID Numbers:
  • MD ∕ 17.07.95
First Posted:
Dec 13, 2017
Last Update Posted:
May 2, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bupivacaine
Naloxone

Study Results

No Results Posted as of May 2, 2018