Phase 3
N=20
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
Bariatric Surgical Pain
Bottom Line
View on ClinicalTrials.gov: NCT01944098 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Postoperative Pain — 3; 4.5; 8; 8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lidocaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain |
3; 3.5; 8; 5.5; 6; 4.5 | — |
| PRIMARY Postoperative Pain |
3; 3.5; 8; 5.5; 6; 4.5 | — |
| PRIMARY Postoperative Pain |
3; 3.5; 8; 5.5; 6; 4.5 | — |
| PRIMARY Postoperative Pain |
3; 3.5; 8; 5.5; 6; 4.5 | — |
Summary
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.
Eligibility Criteria
Inclusion Criteria
- Adult patients between the ages of 18-65 years old
- BMI ≥ 40 kg/m2, ≤ 60 kg/m2
- Undergoing a primary laparoscopic RYGB by Dr. Murr
- Agree to be followed 24 hours postoperatively
- Normal K+ and Mg++ serum levels
Exclusion Criteria
- BMI less than 40 kg/m2, > 60 kg/m2
- Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
- Allergy to lidocaine
- Allergy to hydromorphone or ketorolac
- Allergy to corn or amide anesthetics
- Use of (thioridizine)
- Pregnancy
- Abnormalities of ALT or AST
- Intra-operative diagnosis of cirrhosis or portal hypertension
- Intraoperative complications per surgeon
- Intraoperative extensive adhesions per surgeon
- Chronic pain syndrome and chronic use of narcotics
- Severe back pain secondary to degenerative joint disease
Data sourced from ClinicalTrials.gov (NCT01944098). 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.