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

NCT03372486 | Completed DMC

• 1 other identifier: MD ∕ 17.07.95
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Trauma

Outcome Measures

Primary Outcomes (1)

• Effect of ultra-low dose naloxone on the post operative opioid

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

  for 48 hours after surgery

Secondary Outcomes (6)

• Duration of sensory block

  For 48 hours after surgery

• Duration of motor block

  For 48 hours after surgery

• Onset time of sensory block

  For 48 hours after surgery

• Onset time of motor block

  For 48 hours after surgery

• Severity of post-operative pain

  For 48 hours after surgery

Study Arms (2)

Bupivacaine plus naloxone

ACTIVE COMPARATOR

Patients will receive brachial plexus block using bupivacaine plus naloxone.

Drug: Bupivacaine plus naloxone

Bupivacaine

PLACEBO COMPARATOR

Patients will receive brachial plexus block using bupivacaine.

Drug: Bupivacaine

Interventions

Bupivacaine plus naloxone DRUG

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)

Bupivacaine plus naloxone

Bupivacaine DRUG

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

Bupivacaine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of allergy to the drug of the study.
• Coagulation disorders
• Infection at the puncture site.
• Pregnancy
• Opioid abuse.
• Abuse of tranquilizers

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Central Hospital, emergency Unit

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Naloxone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Doaa G Diab, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 13, 2017
• Study Start: December 18, 2017
• Primary Completion: April 10, 2018
• Study Completion: April 25, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

EG (1)