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

Upper Extremity Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372486
• Other study ID #: MD / 17.07.95
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: April 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 25, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology (ASA) physical state class ? 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

Related Conditions & MeSH terms

• Upper Extremity Trauma

Intervention

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

Locations

Country	Name	City	State
Egypt	Mansoura University, Central Hospital, emergency Unit	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	1st time of analgesic request	First need for rescue opioid after surgery	For 48 hours after surgery