Intravenous Ibuprofen for Laparoscopic Bariatric Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Jacobi Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 24 hours postoperative morphine requirement using IV PCA
Study Overview
Brief Summary
Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.
Detailed Description
Investigators will recruit patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center (100 patients with allowance for 20% drop-offs). Patients will be randomized to IV Ibuprofen versus placebo to test if morphine usage can be decreased, pain control improved, pressure pain thresholds increased and respiratory depression decreased.
Exclusion/withdrawal criteria:
Patients with history of ibuprofen or aspirin allergy, morphine allergy, opioid or psychotropic medication use pre-operatively, patients who would show positive preoperative U-tox screening, patients unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity will be excluded. Patients with GFR<60 or history of GI bleed within 6 weeks will be excluded. Patients will be withdrawn from the study if PCA would have to be discontinued, or the patient would develop acute renal failure, GI bleed or post-surgical bleed. Intention to treat analysis will be performed including the dropouts.
Patients' instructions and protocol:
Patients consented for the study will be educated about morphine PCA for pain control and about pain reporting using NRS-11 and VAS scale at rest and with cough or during incentive spirometry. They will receive instructions about Remmers Sleep Recorder (SagaTech Calgary, Alberta, Canada), which includes continuous oximetry, and device will be provided for overnight home screening preoperatively {Whitelaw,W.A. 2005;}. The sleep recorder data will be reviewed pre-operatively and patients with respiratory disturbance index (RDI, measured as oxygen desaturation event) >15/hour who do not have OSA diagnosis and do not use CPAP will be referred for sleep study and/or CPAP titration before the surgery, Patients will be educated on QST testing using pressure algometry with 1cm2 padded tip {Coronado 2010} and will be given survey questionnaire (postoperative diary) for self-reporting of pain (VAS at rest and with cough), nausea/vomiting, activity and side effects from medications as well as satisfaction with recovery and pain control. Baseline pressure pain thresholds (N/cm2) will be tested at abdomen (area of postoperative hyperalgesia) and the pulp of third finger finger on the right (reference site) using average of three measurements per site.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center
Exclusion Criteria
- •Patients with history of ibuprofen or aspirin allergy
- •morphine allergy
- •opioid or psychotropic medication use pre-operatively
- •positive preoperative U-tox screening
- •unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity
- •GFR <60 or history of GI bleed within 6 weeks
Arms & Interventions
Intravenous Ibuprofen
800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).
Intervention: Intravenous Ibuprofen (Drug)
Saline
IV saline every 6 hours starting preoperatively (5 doses).
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
24 hours postoperative morphine requirement using IV PCA
Time Frame: 24 hours
Will test if IV ibuprofen decrease postoperative morphine requirement.
Secondary Outcomes
- Respiratory depression(24 hours postoperative)
- Pain scores(24 hours postoperatively)
- Pressure pain thresholds(24 hours)
Investigators
Mindaugas Pranevicius
Attending Anesthesiologist, Director of Pain Medicine
Jacobi Medical Center