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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: Clinical Trial NA study, sponsored by University of Texas Southwestern Medical Center.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The primary aim of this study is to compare postoperative pain scores at 24 hours between the subjects who receive ESP block with liposomal bupivacaine and the subjects who receive QL block with liposomal bupivacaine undergoing Total Abdominal Hysterectomy. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.

Interventions

  • PROCEDURE Quadratus Lumborum Block
  • PROCEDURE Erector Spinae Plane block

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-03-20
Est. Completion 2023-03-21
Phase NA

Why NCT04074226 stopped before completion

NCT04074226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Quadratus Lumborum Block is the first listed.

NCT04074226 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04074226's enrollment target sits among peer trials

17 1871st of 2000 higher than 130 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04074226, the US trial registry maintained by the National Library of Medicine. NCT04074226 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.