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

Mansoura University

Status: Completed

Conditions: Upper Extremity Trauma

Treatments: Drug: Bupivacaine; Drug: Bupivacaine plus naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT03372486

MD ∕ 17.07.95

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Bupivacaine plus naloxone

Active Comparator group

Description:

Patients will receive brachial plexus block using bupivacaine plus naloxone.

Treatment:

Drug: Bupivacaine plus naloxone

Bupivacaine

Placebo Comparator group

Description:

Patients will receive brachial plexus block using bupivacaine.

Treatment:

Drug: Bupivacaine