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

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

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.

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

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. Undergoing open gynecologic surgery via a low transverse incision;

2. Analgesic plan includes bilateral single-injection ESP blocks; and

3. Age 18 years or older.

Exclusion Criteria:

1. Morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2);

2. Renal insufficiency (abnormal preoperative creatinine or eGFR );

3. Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks);

4. History of opioid abuse;

5. Any comorbidity which results in moderate or severe functional limitation;

6. Inability to communicate with the investigators or hospital staff;

7. Pregnancy;

8. Planned intrathecal opioids;

9. Incarceration;

10. Known allergy to any study medication; and

11. Any contraindication to perineural catheter insertion (e.g., infection at the catheter insertion site).