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Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02731430
Enrollment
100
Registered
2016-04-07
Start date
2015-12-31
Completion date
2016-04-30
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.

Interventions

DRUGintrathecal morphine

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Total postoperative analgesic consumption.24 hours postoperativethe efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.

Secondary

MeasureTime frameDescription
Visual analogue scale (VAS) scores24 hours postoperativepostoperative pain scores
Time to first request of rescue analgesia.24 hours postoperative
Tolerability as assessed by the incidence of side effects24 hours postoperativethe incidence of side effects

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026