Postoperative PainNCT02678585
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
A study testing Nalbuphine and Lidocaine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Nalbuphine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Mar 2016
- 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
- adult patients
- American Society of Anesthesiologists (ASA) physical status I-II
- age between 20 and 50 years old
- scheduled for elective unilateral short hand surgery
Who cannot join
- allergy to study medications
- body mass index > 35 kg/m2
- patients with sickle cell disease or Reynaud disease
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia
- Conditions
- Postoperative Pain
- Being tested
- Nalbuphine, Lidocaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
53 patients received intravenous regional lidocaine plus nalbuphine
LidocaineDrug
53 patients received intravenous regional lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine | Active comparator | 53 patients received intravenous regional lidocaine plus Nalbuphine Receives: Drug: Nalbuphine |
| Control group | Other | 53 patients received intravenous regional lidocaine Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tourniquet and postoperative pain measured by visual analogue scale
Measured: 4 hours
Secondary outcomes (1)
Cortisol level
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Bakri, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678585
- Sponsor's protocol ID
- 000087161
- Status last verified
- Jun 2018
- First submitted
- 4 Feb 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
- ClinicalTrials.gov ID
- NCT02678585
- Acronym / sponsor ID
- 000087161
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- 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.
The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine | Active comparator | Drug: Nalbuphine53 patients received intravenous regional lidocaine plus Nalbuphine |
| Control group | Other | Drug: Lidocaine53 patients received intravenous regional lidocaine |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult patients
- American Society of Anesthesiologists (ASA) physical status I-II
- age between 20 and 50 years old
- scheduled for elective unilateral short hand surgery
Key exclusion criteria (4 listed)
- allergy to study medications
- body mass index > 35 kg/m2
- patients with sickle cell disease or Reynaud disease
- patient refusal
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 |
|---|---|---|
| Nalbuphine53 patients received intravenous regional lidocaine plus nalbuphine | Drug | Nalbuphine |
| Lidocaine53 patients received intravenous regional lidocaine | Drug | Control group |
Primary outcome
Tourniquet and postoperative pain measured by visual analogue scale
Time frame: 4 hours
1 secondary outcome
Cortisol level
Time frame: 4 hours
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 26 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalbuphine and Lidocaine in people with Postoperative Pain, run by Assiut 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 4 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 26 Jun 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. 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?
Tourniquet and postoperative pain measured by visual analogue scale (time frame: 4 hours). 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 26 Jun 2018.