Upper Extremity Trauma
Conditions
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.
Interventions
DRUGBupivacaine 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)
DRUGBupivacaine
Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ultra-low dose naloxone on the post operative opioid | for 48 hours after surgery | by estimate the analgesic requirements of opioids and the interval between each opioid dose in 48 hour post operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of motor block | For 48 hours after surgery | defined as the time interval between complete paralysis (Lovett rating scale = 0) and complete recovery (Lovett rating scale = 6) |
| Onset time of sensory block | For 48 hours after surgery | defined as the time between the end of the last injection and complete absence of pinprick response in all nerve distribution |
| Duration of sensory block | For 48 hours after surgery | will be defined as the time interval between the complete sensory block (complete absence of pinprick response) and first experience with postoperative pain |
| Severity of post-operative pain | For 48 hours after surgery | will be measured by visual analogue scale (VAS) where 0 was equal to no pain and 10 indicated the worst possible pain |
| 1st time of analgesic request | For 48 hours after surgery | First need for rescue opioid after surgery |
| Onset time of motor block | For 48 hours after surgery | defined as the time between the end of the last injection and complete paralysis (Lovett rating scale = 0) in all nerve distributions |
Countries
Egypt
Outcome results
None listed