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

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.

Conditions

• Postoperative Pain

Interventions

PROCEDURE

Continuous Erector Spinae Plane Nerve Block

To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery.

PROCEDURE

Continuous Quadratus Lumborum Nerve Block

To be administered to subjects in the active comparator group receiving primary major abdominal surgery.

PROCEDURE

Single Erector Spinae Plane Nerve Block

To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery.

PROCEDURE

Single Quadratus Lumborum Nerve Block

To be administered to subjects in the experimental group receiving primary major abdominal surgery.

DRUG

Lidocaine IV

To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group.

DRUG

Ropivacaine 0.5% Injectable Solution

To be used in both treatment arms as nerve block initial bolus injection.

DRUG

Dexamethasone

To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.

DRUG

Dexmedetomidine

To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.

DRUG

Lidocaine

To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.

Sponsors & Collaborators

• Jeremy Kearns

  lead OTHER

Principal Investigators

• Jacques E Chelly, MD, PhD, MBA · University of Pittsburgh Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-26

Primary Completion

2022-08-18

Completion

2022-08-18

FDA Drug

Yes

Countries

• United States

Study Locations