drugset / Trial / NCT04208516

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

NCT04208516 ↗

Phase 4 Terminated 17 enrolled Jeremy Kearns
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-05-26
Primary completion
2022-08-18
Completion
2022-08-18

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment was unable to be obtained in a timely fashion, so the study was stopped.”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg —
Subject Dexmedetomidine Other / unclassified 20 ug —
Subject Dexmedetomidine Other / unclassified 30 ug —
Subject Lidocaine Other / unclassified 0.25 % Intravenous
Subject Lidocaine Other / unclassified 50 mg Intravenous
Background Ropivacaine Other / unclassified 0.5 % —
Background Ropivacaine Other / unclassified 20 ml —

Indications

No indication recorded.