Obesity Clinical Trial
Official title:
Intravenous Ibuprofen for Laparoscopic Bariatric Surgery
Verified date | September 2015 |
Source | Jacobi Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Jacobi Medical Center | Cumberland Pharmaceuticals, Sagatech Electronics Inc, Alberta, Canada |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Nausea/vomiting | Compare incidence of nausea vomiting between groups. | 24 hours | No |
Other | Transfusion requirement | Compare incidence of blood transfusions between groups. | 3 days | Yes |
Other | Urinary retention | Incidence of recatheterization after foley removal between groups. | 3 days | No |
Other | Surgical bleeding | Incidence of reoperation for bleeding in ibuprofen and control groups. | 30 days | Yes |
Other | Incidence of renal dysfunction | Compare preoperative versus discharge GFR in ibuprofen and control groups. | 3 days | Yes |
Other | Time to oral intake | Time to clears in ibuprofen and control groups. | 3 days | No |
Other | Return of baseline activity | Time to baseline activity in ibuprofen and control groups | 30 days | No |
Other | Time patient meets discharge criteria from the PACU (hours) | 24 hours | No | |
Other | Time to discharge from PACU (hours) | 24 hours | No | |
Other | Time to discharge from hospital (hours) | 1 week | No | |
Other | Time to ambulation (hours) | 3 days | No | |
Other | Incidence of readmission within 4 weeks | 4 weeks | Yes | |
Other | Incidence of reoperation within 4 weeks | 4 weeks | Yes | |
Other | Incidence of DVT | 30 days | Yes | |
Other | Max temperature | 3 days | No | |
Other | Time to oral tolerance (clears, solids) (hours) | 3 days | No | |
Other | Antiemetic requirement (number of doses) | 24 hours | No | |
Other | Time to bowel movement (hours) | 1 week | No | |
Other | Incidence of over sedation (sedation score 3 and 4) | 24 hours | Yes | |
Other | Naloxone requirement | 24 hours | Yes | |
Other | Patient satisfaction scores | 30 days | No | |
Other | Time to out of bed to chair (hours) | 3 days | No | |
Other | Time to stand-up (hours) | 3 days | No | |
Primary | 24 hours postoperative morphine requirement using IV PCA | Will test if IV ibuprofen decrease postoperative morphine requirement. | 24 hours | No |
Secondary | Respiratory depression | Compare respiratory disturbance index preoperatively versus postoperatively and incidence of hypoxia (SpO2 <95, <90 and <80%) in ibuprofen and placebo groups. | 24 hours postoperative | Yes |
Secondary | Pain scores | Area under curve for pain scores at rest (AUCr) and with cough (AUCa). | 24 hours postoperatively | No |
Secondary | Pressure pain thresholds | Preoperative versus postoperative pressure pain threshold (PPT) will be measured to assess effect of ibuprofen on PPT (important for mobilization). | 24 hours | No |
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