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

NCT ID: NCT03372486

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-18
• Study Completion Date: 2018-04-25

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.

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.

Conditions

Upper Extremity Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine plus naloxone

Patients will receive brachial plexus block using bupivacaine plus naloxone.

Group Type: ACTIVE_COMPARATOR

Bupivacaine plus naloxone

Intervention Type: 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

Patients will receive brachial plexus block using bupivacaine.

Group Type: PLACEBO_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doaa G Diab, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Anesthesia and Surgical Intensive Care

Locations

Mansoura University, Central Hospital, emergency Unit

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MD ∕ 17.07.95

Identifier Type: -

Identifier Source: org_study_id