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

NCT04208516 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY19100057
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intravenous lidocaine; erector spinae plane block; quadratus lumborum block; thoracic surgery; abdominal surgery; continuous peripheral nerve block

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption After Surgery

  Opioids will be converted to oral morphine equivalents

  24 hours after surgery

Secondary Outcomes (16)

• Opioid Consumption After Surgery

  48 hours after surgery

• Opioid Consumption After Surgery

  72 hours after surgery

• Pain After Surgery

  6 hours after surgery

• Pain After Surgery

  12 hours after surgery

• Pain After Surgery

  24 hours after surgery

Study Arms (2)

Continuous nerve blocks

ACTIVE COMPARATOR

A total of 30 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery , or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution.

Procedure: Continuous Erector Spinae Plane Nerve Block; Procedure: Continuous Quadratus Lumborum Nerve Block; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Lidocaine

Single nerve blocks plus IV lidocaine infusion

EXPERIMENTAL

A total of 30 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution.

Procedure: Single Erector Spinae Plane Nerve Block; Procedure: Single Quadratus Lumborum Nerve Block; Drug: Lidocaine IV; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Dexamethasone; Drug: Dexmedetomidine

Interventions

Continuous Erector Spinae Plane Nerve Block PROCEDURE

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

Continuous nerve blocks

Continuous Quadratus Lumborum Nerve Block PROCEDURE

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

Continuous nerve blocks

Single Erector Spinae Plane Nerve Block PROCEDURE

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

Single nerve blocks plus IV lidocaine infusion

Single Quadratus Lumborum Nerve Block PROCEDURE

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

Single nerve blocks plus IV lidocaine infusion

Lidocaine IV DRUG

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

Single nerve blocks plus IV lidocaine infusion

Ropivacaine 0.5% Injectable Solution DRUG

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

Continuous nerve blocks; Single nerve blocks plus IV lidocaine infusion

Dexamethasone DRUG

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.

Single nerve blocks plus IV lidocaine infusion

Dexmedetomidine DRUG

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.

Single nerve blocks plus IV lidocaine infusion

Lidocaine DRUG

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

Continuous nerve blocks

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Primary unilateral VATS or major abdominal surgery
• BMI 20-36, weight ≥ 50kg
• Male and Female
• All races

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeremy Kearns: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (9)

• Akerman M, Pejcic N, Velickovic I. A Review of the Quadratus Lumborum Block and ERAS. Front Med (Lausanne). 2018 Feb 26;5:44. doi: 10.3389/fmed.2018.00044. eCollection 2018.

  PMID: 29536008 BACKGROUND

• Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae plane block provides comparable analgesia to thoracic paravertebral block following thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 2019 Apr;7(8):174. doi: 10.21037/atm.2019.03.53.

  PMID: 31168455 BACKGROUND

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 BACKGROUND

• Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.

  PMID: 27749354 BACKGROUND

• MacFater WS, Rahiri JL, Lauti M, Su'a B, Hill AG. Intravenous lignocaine in colorectal surgery: a systematic review. ANZ J Surg. 2017 Nov;87(11):879-885. doi: 10.1111/ans.14084. Epub 2017 Jul 5.

  PMID: 28677829 BACKGROUND

• Masic D, Liang E, Long C, Sterk EJ, Barbas B, Rech MA. Intravenous Lidocaine for Acute Pain: A Systematic Review. Pharmacotherapy. 2018 Dec;38(12):1250-1259. doi: 10.1002/phar.2189. Epub 2018 Nov 9.

  PMID: 30303542 BACKGROUND

• Njathi CW, Johnson RL, Laughlin RS, Schroeder DR, Jacob AK, Kopp SL. Complications After Continuous Posterior Lumbar Plexus Blockade for Total Hip Arthroplasty: A Retrospective Cohort Study. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):446-450. doi: 10.1097/AAP.0000000000000589.

  PMID: 28277419 BACKGROUND

• Shanthanna H, Moisuik P, O'Hare T, Srinathan S, Finley C, Paul J, Slinger P. Survey of Postoperative Regional Analgesia for Thoracoscopic Surgeries in Canada. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1750-1755. doi: 10.1053/j.jvca.2018.01.003. Epub 2018 Jan 5.

  PMID: 29402627 BACKGROUND

• Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

  PMID: 29864216 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Dexamethasone; Dexmedetomidine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides

Limitations and Caveats

We were not able to enroll enough subjects in a timely manner and our enrollment numbers did not reach the goal of our pilot study.

Results Point of Contact

• Title: Jeremy Kearns, MD
• Organization: UPMC

kearnsjt@upmc.edu

412-623-5296

Study Officials

• Jacques E Chelly, MD, PhD, MBA

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For study participants, the investigator placing the block will record in the narrative that "this patient is a study participant and received Paravertebral block with ESP approach" or "this patient is a study participant and received TAP block with QL approach". By documenting blocks in this way, the research team member collecting the data will be blinded to whether the patient received continuous block with 0.5% ropivacaine, or single block with 0.5% ropivacaine, dexamethasone, and dexmedetomidine.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Two groups of patients will be studied simultaneously. One group will receive continuous peripheral nerve blocks and the other group will receive single blocks plus postoperative intravenous lidocaine infusion.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: May 26, 2021
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)