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NCT Number: NCT03372486

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

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.

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Key information

Conditions

Upper Extremity Trauma

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Central Hospital, emergency Unit

Al Mansurah, Dakahlia Governorate, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine plus naloxone

Drug

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

Drug

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

Primary outcomes

  1. Effect of ultra-low dose naloxone on the post operative opioid

    Time frame: 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 outcomes

  1. Duration of sensory block

    Time frame: 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

  2. Duration of motor block

    Time frame: For 48 hours after surgery

    defined as the time interval between complete paralysis (Lovett rating scale = 0) and complete recovery (Lovett rating scale = 6)

  3. Onset time of sensory block

    Time frame: 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

  4. Onset time of motor block

    Time frame: 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

  5. Severity of post-operative pain

    Time frame: 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

  6. 1st time of analgesic request

    Time frame: For 48 hours after surgery

    First need for rescue opioid after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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