An interventional study of Bupivacaine plus naloxone and Bupivacaine in Upper Extremity Trauma, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
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.
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.
Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive brachial plexus block using bupivacaine plus naloxone.
Drug: Bupivacaine plus naloxone
Patients will receive brachial plexus block using bupivacaine.
Drug: Bupivacaine
Drug pages: Bupivacaine · 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)
Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline
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
Time frame: for 48 hours after surgery
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
Time frame: For 48 hours after surgery
Duration of motor block
defined as the time interval between complete paralysis (Lovett rating scale = 0) and complete recovery (Lovett rating scale = 6)
Time frame: For 48 hours after surgery
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
Time frame: For 48 hours after surgery
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
Time frame: For 48 hours after surgery
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
Time frame: For 48 hours after surgery
1st time of analgesic request
First need for rescue opioid after surgery
Time frame: For 48 hours after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bupivacaine · Naloxone