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ESP vs QL for Total Abdominal Hysterectomy

NCT04074226 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-04-04

No results posted yet for this study

Summary

Patients undergoing open total abdominal hysterectomy (n=82) at Parkland Memorial Hospital will be randomized into one of two groups to receive either ultrasound-guided bilateral ESP block with liposomal bupivacaine (Group 1) or ultrasound-guided bilateral QL block with liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 72 hours postoperatively. Anesthesia providers will identify potential subjects during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment. There will be no incentive or payment to the patients.

Patients in Group 1 will receive ultrasound-guided bilateral ESP block in the preoperative holding area prior to surgery. Patients in Group 2 will receive ultrasound-guided QL block in the preoperative holding area prior to surgery. All patients will have general anesthesia per previously established Parkland Enhanced Recovery After Surgery (ERAS) protocols. Postoperatively, patients in both Groups will receive acetaminophen 1000 mg orally every 8 hours, meloxicam 15 mg orally every 24 hours, and immediate-release oxycodone 5 - 10mg orally every 4 hours as needed for breakthrough pain.

The postoperative analgesia will be documented using the Numeric Rating Scale (0-10 scale where 0=no pain and 10=worst pain). In addition, total opioid dose over the 72-hours study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue anti-emetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours, postoperatively by an investigator blinded to group allocation.

Conditions

  • Postoperative Pain

Interventions

PROCEDURE

Erector Spinae Plane block

The Erector Spinae Plane (ESP) block is a new block first described in 2016 which blocks terminal branches of the lower thoracic and lumbar nerve roots. It is performed by injection of local anesthetic in the fascial plane below the erector spinae muscle group.

PROCEDURE

Quadratus Lumborum Block

Ultrasound-guided QL block has been reported to provide effective analgesia in patients undergoing lower abdominal surgical procedures, including in patients undergoing abdominal hysterectomy. Ultrasound guidance offers a number of advantages, including the ability to visualize the anatomy, perform real-time navigation, and direct observation of local anesthetic spread. The QL block is performed via ultrasound-guided injection of local anesthetic in the fascial planes above or below the QL muscle

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • John C Alexander, MD · UT Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2023-03-20
Completion
2023-03-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074226 on ClinicalTrials.gov