Clinical trial NCT03372486: Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on Post-operative Opioi
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Trauma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Effect of ultra-low dose naloxone on the post operative opioid
timeFrame: for 48 hours after surgery
Secondary outcomes:
measure: Duration of sensory block
timeFrame: For 48 hours after surgery
measure: Duration of motor block
timeFrame: For 48 hours after surgery
measure: Onset time of sensory block
timeFrame: For 48 hours after surgery
measure: Onset time of motor block
timeFrame: For 48 hours after surgery
measure: Severity of post-operative pain
timeFrame: For 48 hours after surgery
measure: 1st time of analgesic request
timeFrame: For 48 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Central Hospital, emergency Unit
state: Dakahlia
Study officials:
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Doaa G Diab, MD
role: PRINCIPAL_INVESTIGATOR
References: