Phase 3
N=96
Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens
Morbid Obesity · Postoperative Pain · Postoperative Bowel Function · Postoperative Ambulation
Bottom Line
View on ClinicalTrials.gov: NCT01249872 ↗Enrolled (actual)
96
Serious AEs
11.5%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in Pain Scores (Visual Analogue Scale) — 1.4; 1.6; 1.6; 0.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE (Drug); GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE (Drug); GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE (Drug); GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE (Drug); GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE (Drug); GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Patras
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Scores (Visual Analogue Scale) |
1.4; 1.6; 1.6; 0.8; 1.1; 0.8 | — |
| SECONDARY Time to Postoperative Bowel Recovery |
56.6; 70.9; 67.1; 55.6; 58.6; 63.9 | — |
| SECONDARY Time to First Postoperative Ambulation |
19.0; 19.9; 19.1; 20.7; 21.4; 20.6 | — |
| SECONDARY Consumption of Levobupivacaine at 24h and 48 h Postoperatively |
132.9; 178.8; 165.6; 325.7; 241.9; 203.1 | — |
| SECONDARY Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively |
4.8; 5.8; 6.8; 4.8; 5.8; 6.8 | — |
| SECONDARY Change From Baseline of Spirometric Values |
63.2; 69.3; 68.3; 71.7; 66.4; 66.8 | — |
Summary
Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has been studied, but up to date no data are available concerning the use of thoracic epidural patient-controlled analgesia regarding the use of levobupivacaine combined with morphine in morbidly obese patients. The investigators' aim in this prospective, randomized, double-blinded study was to compare the analgesic effectiveness, the dose requirements and side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine combined with a continuous epidural administration of morphine, with or without a loading dose, after open gastric bypass for morbid obesity.
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) > 50
- Age < 50
- Patients written consent to participate in the study
Exclusion Criteria
- Cardiovascular disease (valvular and ischemic heart disease)
- Patients refusal to participate in the study
- Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
- Active psychiatric disease requiring treatment
- Redo surgery
Data sourced from ClinicalTrials.gov (NCT01249872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.