Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain.

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A multimodal analgesic regimen including regional anesthesia is used at UPMC Shadyside for primary thoracic and major abdominal surgeries. The current standard-of-care regional anesthesia techniques include Erector Spinae Plane (ESP) block for video assisted thorascopic surgery (VATS) and Quadratus Lumborum (QL) block for major abdominal surgery. These blocks are routinely administered as a continuous catheter technique in order to extend the duration of postoperative analgesia. Although rare, continuous nerve block techniques carry risks and limitations, including catheter dislodgement, migration, kinking and leaking at the site, bleeding, and infection. They are also much more expensive to perform and maintain than single-injection nerve blocks at this institution. Perioperative intravenous (IV) lidocaine is one of the safest local anesthetics, and its use has been shown to provide analgesia and reduce opioid requirements. Furthermore, it has been hypothesized that part of the analgesic efficacy of continuous peripheral nerve blocks may be due to the systemic effects of the local anesthetic infused at the site. Therefore, it is possible that the combination of a single block followed by an infusion of IV lidocaine may provide the same benefits as a continuous nerve block at a lower cost. The purpose of this study is to show that a single block technique plus IV lidocaine is non-inferior to a continuous block technique. For the purpose of this study we chose two surgical models--VATS and major abdominal surgery--and ESP and QL blocks, respectively. The study will be conducted as a prospective, randomized (1:1), open-label, active-comparator, noninferiority trial. The study will prospectively investigate the efficacy of continuous block versus single block plus IV lidocaine infusion for postoperative pain management in patients undergoing primary unilateral VATS or primary major abdominal surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gabriel Wilner, MD; Jacques E. Chelly
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Dexmedetomidine; Lidocaine; Ropivacaine

Criteria

Inclusion Criteria:

• 18-90 years old

• Primary unilateral VATS or major abdominal surgery

• BMI 20-36, weight ≥ 50kg

• Male and Female

• All races

Exclusion Criteria:

• Patient refusal

• Inpatient status at the time of surgery

• ASA class 4 or greater

• Pregnancy

• Non-English speaking or inability to participate in the study

• Patients with coagulopathy or on therapeutic anticoagulation

• Chronic steroid use

• Opioid use disorder

• Contraindication to performing any of the proposed blocks - active infection at the block site, systemic infection, allergy to local anesthetic medications

• Patients undergoing second surgery or urgent/emergent surgery

• Patients weighing < 50kg

• History of chronic pain and/or opioid tolerant

• Anticipated requirement for patient-controlled analgesia (PCA)

• Allergy or intolerance to any medication specified in the study protocol or postoperative pain management regimen

• Liver disease