Phase 3 Completed N=20 Randomized Triple-blind Prevention

Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

Bariatric Surgical Pain

Source: ClinicalTrials.gov NCT01944098 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcomePrimary: Postoperative Pain — 3; 4.5; 8; 8 units on a scale

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain	3; 3.5; 8; 5.5; 6; 4.5	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.