Continuous Erector Spinae Plane Blocks to Treat Postoperative Pain After Open Gynecologic Procedures Via a Low Transverse (Pfannenstiel) Incision

NCT05082155 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Bilateral cESPB for GYN Surg
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Open gynecologic surgery can be very painful. With the goal of minimizing the use of opioids (with undesired side effects and potential for abuse), the investigators often administer a type of peripheral nerve block in which the investigators put local anesthetic-or, numbing medicine-near the nerves that go to the surgical area which helps to numb the area and decrease pain following surgery. These blocks with a single-injection of local anesthetic are called erector spinae plane (ESP) blocks, and they are applied on each side of the body since each injection affects only that one side. However, the numbing medication typically lasts for only 16-20 hours. For other peripheral nerve blocks, this duration can be increased with the insertion of a catheter-a tiny tube smaller than a piece of spaghetti-followed by an infusion of additional local anesthetic. However, the effects of the various peripheral nerve blocks are determined by the anatomy and physiology of the specific peripheral nerve, with an infusion resulting in dramatic benefits for one nerve yet having no effect for another. The potential benefits and risks of adding a catheter and subsequent local anesthetic infusion to a single-injection ESP block remain unknown. The investigatorstherefore propose a randomized, triple-masked, placebo-controlled, split-body clinical trial to determine the potential benefits and risks of adding the infusion to single-injection ESP blocks.

Conditions

Surgical Incision; Pain, Postoperative; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• "Average" pain during postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  The "average" pain measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  Postoperative day 1 (00:01 through afternoon data-collection time point)

Secondary Outcomes (10)

• Maximum pain during postoperative day 1 which is the highest pain measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0=no pain, 10=worst pain

  Postoperative day 1 (00:01 through afternoon data-collection time point)

• Pain during coughing, postoperative day 1 which is the highest pain experienced during coughing using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0= no pain and 10= worst pain

  Postoperative Day 1 at the time of the data collection time point

• "Average" pain during postoperative day 2 which is the "average" pain measured using the numeric rating scale, collected postoperative day 2 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10=worst pain

  Postoperative day 2 (00:01 through afternoon data-collection time point)

• Maximum pain during postoperative day 2 which is the highest pain experienced during coughing using the numeric rating scale, collected postoperative day 2. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  Postoperative day 2 (00:01 through afternoon data-collection time point)

• Pain during coughing, postoperative day 2 which is tthe highest pain experienced during coughing using the numeric rating scale, collected postoperative day 2. pain

  Postoperative Day 2 at the time of the data collection time point

Other Outcomes (13)

• Surgical start time

  Day of surgery

• Surgical duration

  Day of surgery

• Indication for surgery

  Day of surgery

Study Arms (2)

Right sided catheter bupivacaine 0.25% and left sided catheter normal saline

EXPERIMENTAL

This is a split body study. Bilateral erector spinae plane catheters will be inserted and study fluid is administered bilaterally. Bupivacaine 0.25 will be administered through the right-sided catheter while normal saline will be administered through the left-sided catheter. Both infusion pumps will be programmed to deliver a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.

Drug: Bupivacaine 0.25%; Drug: Normal Saline

Right sided catheter normal saline and left sided catheter bupivacaine 0.25%

EXPERIMENTAL

This is a split body study. Bilateral erector spinae plane catheters will be inserted and study fluid is administered bilaterally. Normal saline will be administered through the right-sided catheter while bupivacaine 0.25% will be administered through the left-sided catheter. Both infusion pumps will be programmed to deliver a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.

Drug: Bupivacaine 0.25%; Drug: Normal Saline

Interventions

Bupivacaine 0.25% DRUG

Bupivacaine 0.25% will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.

Right sided catheter bupivacaine 0.25% and left sided catheter normal saline; Right sided catheter normal saline and left sided catheter bupivacaine 0.25%

Normal Saline DRUG

Normal saline will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.

Also known as: Placebo

Right sided catheter bupivacaine 0.25% and left sided catheter normal saline; Right sided catheter normal saline and left sided catheter bupivacaine 0.25%

Eligibility Criteria

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

You may qualify if:

• Undergoing open gynecologic surgery via a low transverse incision;
• Analgesic plan includes bilateral single-injection ESP blocks; and
• Age 18 years or older.

You may not qualify if:

• Morbid obesity as defined by a body mass index \> 40 (BMI=weight in kg / \[height in meters\]2);
• Renal insufficiency (abnormal preoperative creatinine or eGFR );
• Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks);
• History of opioid abuse;
• Any comorbidity which results in moderate or severe functional limitation;
• Inability to communicate with the investigators or hospital staff;
• Pregnancy;
• Planned intrathecal opioids;
• Incarceration;
• Known allergy to any study medication; and
• Any contraindication to perineural catheter insertion (e.g., infection at the catheter insertion site).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University Of California San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Surgical Wound; Pain, Postoperative; Acute Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Brian M Ilfeld, MD,MS

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will be created by the University of California San Diego Investigational Drug Service. Investigational pharmacists will prepare all study solutions as determined by the randomization list. Bupivacaine and normal saline are indistinguishable in appearance, and therefore investigators, participants, and all clinical staff will be masked to treatment group assignment for the duration of the enrollment and data collection period. Unmasking will not occur until statistical analysis is complete (termed "triple masking").
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: This is a split-body study in which each study subject receives both treatments: one on each side of the body. Which treatment is applied to which side of the body is randomized (and masked).

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 18, 2021
• Study Start: January 1, 2022
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)