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

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Trauma
• Intervention / Treatment: Drug: Bupivacaine plus naloxone; Drug: Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 050
      • Mansoura University, Central Hospital, emergency Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of sensory block	will be defined as the time interval between the complete sensory block (complete absence of pinprick response) and first experience with postoperative pain	For 48 hours after surgery
Duration of motor block	defined as the time interval between complete paralysis (Lovett rating scale = 0) and complete recovery (Lovett rating scale = 6)	For 48 hours after surgery
Onset time of sensory block	defined as the time between the end of the last injection and complete absence of pinprick response in all nerve distribution	For 48 hours after surgery
Onset time of motor block	defined as the time between the end of the last injection and complete paralysis (Lovett rating scale = 0) in all nerve distributions	For 48 hours after surgery
Severity of post-operative pain	will be measured by visual analogue scale (VAS) where 0 was equal to no pain and 10 indicated the worst possible pain	For 48 hours after surgery
1st time of analgesic request	First need for rescue opioid after surgery	For 48 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Doaa G Diab, MD, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2017
• Primary Completion (ACTUAL): April 10, 2018
• Study Completion (ACTUAL): April 25, 2018

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Narcotic Antagonists; Anesthetics, Local; Naloxone; Bupivacaine
• Other Study ID Numbers: MD ∕ 17.07.95

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No