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NCT04074226 · ClinicalTrials.gov registry record · NA
ESP vs QL for Total Abdominal Hysterectomy
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT04074226 is a NA study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 17 participants.
The verdict
NCT04074226, a NA study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
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.
Interventions
- PROCEDURE Quadratus Lumborum Block
- PROCEDURE Erector Spinae Plane block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-03-20 |
| Est. Completion | 2023-03-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04074226
The ClinicalTrials.gov registry entry for NCT04074226 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Quadratus Lumborum Block is the first listed.
NCT04074226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04074226 about?
NCT04074226 is a clinical study titled "ESP vs QL for Total Abdominal Hysterectomy". 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 ...
What is the current status of trial NCT04074226?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2021-03-20. Estimated completion is 2023-03-21.
What interventions are being tested in trial NCT04074226?
The interventions under investigation include: Quadratus Lumborum Block (PROCEDURE), Erector Spinae Plane block (PROCEDURE).
Who is sponsoring clinical trial NCT04074226?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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