Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 postoperative-pain
Started Dec 2015
Shorter than P25 for phase_2 postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 3, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedApril 7, 2016
April 1, 2016
3 months
April 3, 2016
April 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Total postoperative analgesic consumption.
the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.
24 hours postoperative
Secondary Outcomes (3)
Visual analogue scale (VAS) scores
24 hours postoperative
Time to first request of rescue analgesia.
24 hours postoperative
Tolerability as assessed by the incidence of side effects
24 hours postoperative
Study Arms (2)
group I: morphine group
ACTIVE COMPARATORreceived 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 COMPARATORreceived 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
Interventions
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.
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia, icu, and pain management
Study Record Dates
First Submitted
April 3, 2016
First Posted
April 7, 2016
Study Start
December 1, 2015
Primary Completion
March 1, 2016
Study Completion
April 1, 2016
Last Updated
April 7, 2016
Record last verified: 2016-04