Morbid Obesity.
Conditions
Interventions
Trade Name: Chirocaine
Product Name: Levobupivacaine
Product Code: Levobupivacaine
Pharmaceutical Form: Injection*
Pharmaceutical form o
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who will be invited to participate in the study will be English-speaking Euro-Caucasian women between 18 and 60 years of age with a body mass index between 35 and 55. All Patients will be scheduled to undergo bariatric surgery with Roux loop formation for morbid obesity. Surgery will be performed at SJUH and the Leeds BUPA Hospital between April 2005 and December 2005. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patient refusal. 2. Prior enrolment in an alternative investigation. 3. Age 60 years. 4. Body mass index >55 5. Allergy or intolerance to any of the study drugs including non-steroidal anti-inflammatories. This includes diabetic patients with proteinuria in whom NSAIDS are relatively contraindicated. 6. Inability to understand or use the VAS for post-operative assessment. 7. Pregnancy and lactation. 8. Previous upper abdominal surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether surgical infiltration of the rectus abdominus muscle with Levobupivacaine (Rectus Sheath Block) prior to wound closure improves post-operative patient satisfaction, post-operative pain scores and reduces patient controlled analgesia (PCA) morphine consumption following open gastric bypass for the treatment of morbid obesity via an upper abdominal midline incision. Our Primary endpoint will be post-operative morphine PCAS use. ; Secondary Objective: Our Secondary endpoints will be: 1. Serial post-operative pain score as measured by VAS 2. Patient satisfaction as measured by VAS. 3. Total PCA demands. 4. Time course of analgesic use. 5. Post-operative sedation scores. ;Primary end point(s): Our Primary endpoint will be post-operative morphine PCAS use. | — |
Countries
United Kingdom
Outcome results
None listed