Postoperative PainPhase 2/3NCT02731430
Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery
A Phase 2/3 study testing intrathecal morphine and intrathecal saline in people with Postoperative Pain, run by Assiut University.
Trial summary
this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery. 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?
- intrathecal morphine and intrathecal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Apr 2016
- Phase
- Phase 2/3
- 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 Anesthesia (ASA) II-III patients.
- Aged 30-50 years.
- The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.
Who cannot join
- Patients with a known allergy to the study drugs.
- Advanced cardiac, respiratory, renal or hepatic disease.
- Coagulation disorders.
- Infection at or near the site of intrathecal injection.
- Drug or alcohol abuse.
- Psychiatric illnesses that may interfere with perception and assessment of pain.
About this study
Official title: Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery
this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.
- Conditions
- Postoperative Pain
- Being tested
- intrathecal morphine, intrathecal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal morphineDrug
received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
intrathecal salineDrug
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| group I: morphine group | Active comparator | received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. Receives: Drug: intrathecal morphine |
| group II: control group | Placebo comparator | received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. Receives: Drug: intrathecal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative analgesic consumption.
the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.
Measured: 24 hours postoperative
Secondary outcomes (3)
Visual analogue scale (VAS) scores
postoperative pain scores
Measured: 24 hours postoperative
Time to first request of rescue analgesia.
Measured: 24 hours postoperative
Tolerability as assessed by the incidence of side effects
the incidence of side effects
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionApr 2016 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731430
- Sponsor's protocol ID
- 274
- Status last verified
- Apr 2016
- First submitted
- 3 Apr 2016
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02731430
- Acronym / sponsor ID
- 274
- Conditions
- Postoperative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 7 Apr 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.
this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I: morphine group | Active comparator | Drug: intrathecal morphinereceived 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. |
| group II: control group | Placebo comparator | Drug: intrathecal salinereceived 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesia (ASA) II-III patients.
- Aged 30-50 years.
- The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.
Key exclusion criteria (6 listed)
- Patients with a known allergy to the study drugs.
- Advanced cardiac, respiratory, renal or hepatic disease.
- Coagulation disorders.
- Infection at or near the site of intrathecal injection.
- Drug or alcohol 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 |
|---|---|---|
| intrathecal morphinereceived 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. | Drug | group I: morphine group |
| intrathecal salinereceived 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. | Drug | group II: control group |
Primary outcome
Total postoperative analgesic consumption.
Time frame: 24 hours postoperative
the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.
3 secondary outcomes
Visual analogue scale (VAS) scores
Time frame: 24 hours postoperative
Time to first request of rescue analgesia.
Time frame: 24 hours postoperative
Tolerability as assessed by the incidence of side effects
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intrathecal morphine and intrathecal saline in people with Postoperative Pain, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Total postoperative analgesic consumption. (time frame: 24 hours postoperative). 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 7 Apr 2016.