Upper Extremity TraumaNCT03372486
Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on Post-operative Opioi
A study testing Bupivacaine plus naloxone and Bupivacaine in people with Upper Extremity Trauma, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Upper Extremity Trauma
- What is being tested?
- Bupivacaine plus naloxone and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2017to 25 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of allergy to the drug of the study.
- Coagulation disorders
- Infection at the puncture site.
- Pregnancy
- Opioid abuse.
- Abuse of tranquilizers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University, Central Hospital, emergency Unit
Al Mansurah, Dakahlia Governorate, 050
About this study
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
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.
Read the 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.
- Conditions
- Upper Extremity Trauma
- Being tested
- Bupivacaine plus naloxone, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine plus naloxoneDrug
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)
BupivacaineDrug
Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine plus naloxone | Active comparator | Patients will receive brachial plexus block using bupivacaine plus naloxone. Receives: Drug: Bupivacaine plus naloxone |
| Bupivacaine | Placebo comparator | Patients will receive brachial plexus block using bupivacaine. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: for 48 hours after surgery
Secondary outcomes (6)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: For 48 hours after surgery
1st time of analgesic request
First need for rescue opioid after surgery
Measured: For 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start18 Dec 2017
- Primary completion10 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity TraumaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doaa G Diab, MD, Principal investigator, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372486
- Sponsor's protocol ID
- MD ∕ 17.07.95
- Status last verified
- Apr 2018
- First submitted
- 7 Dec 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03372486
- Acronym / sponsor ID
- MD ∕ 17.07.95
- Conditions
- Upper Extremity Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine plus naloxone | Active comparator | Drug: Bupivacaine plus naloxonePatients will receive brachial plexus block using bupivacaine plus naloxone. |
| Bupivacaine | Placebo comparator | Drug: BupivacainePatients will receive brachial plexus block using bupivacaine. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of allergy to the drug of the study.
- Coagulation disorders
- Infection at the puncture site.
- Pregnancy
- Opioid abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine plus naloxonePatients 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) | Drug | Bupivacaine plus naloxone |
| BupivacainePatients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline | Drug | Bupivacaine |
Primary outcome
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
6 secondary outcomes
Duration of sensory block
Time frame: For 48 hours after surgery
Duration of motor block
Time frame: For 48 hours after surgery
Onset time of sensory block
Time frame: For 48 hours after surgery
Onset time of motor block
Time frame: For 48 hours after surgery
Severity of post-operative pain
Time frame: For 48 hours after surgery
1st time of analgesic request
Time frame: For 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa G Diab, MD principal investigator
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine plus naloxone and Bupivacaine in people with Upper Extremity Trauma, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ultra-low dose naloxone on the post operative opioid (time frame: for 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.