ESP vs QL for Total Abdominal Hysterectomy
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|ClinicalTrials.gov Identifier: NCT04074226|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : April 14, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Procedure: Erector Spinae Plane block Procedure: Quadratus Lumborum Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||No other parties will be masked|
|Official Title:||Erector Spinae Plane (ESP) Block With Liposomal Bupivacaine Versus Quadratus Lumborum (QL) Block With Liposomal Bupivacaine for Postoperative Pain Management After Open Total Abdominal Hysterectomy: A Prospective Randomized Controlled Trial|
|Actual Study Start Date :||March 20, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Ultrasound-guided ESP block with liposomal bupivacaine
For the ESP block, the transducer will be placed parasagittally at the level of the tip of the scapula and the anesthesiologist will scan in a craniocaudal manner to identify the ipsilateral T10 transverse process and overlying erector spinae muscle. Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the muscle and transverse process. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site.
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.
Active Comparator: Ultrasound-guided QL block with liposomal bupivacaine
For the QL block, the transducer will be placed transversely over the lumbar spine at the level of the iliac crest. Then, the anesthesiologist will scan laterally to identify the ipsilateral L3 transverse process, psoas muscle, and quadratus lumborum muscle to identify the "Shamrock Sign" (7). Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the quadratus lumborum muscle and psoas muscle. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the two muscles. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site.
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
- Postoperative pain (NRS = numeric rating scale) at 24 hours [ Time Frame: 24 hours ]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.
- Postoperative Pain (NRS = numeric rating scale) at 48 hours [ Time Frame: 48 hours ]One secondary objectives is to compare pain scores at 48 hours. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.
- Postoperative Pain (NRS = numeric rating scale) at 72 hours [ Time Frame: 72 hours ]Another secondary objective is to compare pain scores at 48 hours and 72 hours. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.
- Opioid Use (oral morphine equivalents) [ Time Frame: 24 hours ]Another secondary objective is to assess cumulative opioid consumption during the first 24-hours postoperatively. The investigators will convert all opioids consumed in this time from to oral morphine equivalents.
- Block Time (minutes) [ Time Frame: 1 hour ]Antoher secondary objective is to assess the time to perform the blocks as measured in minutes.
- Ambulation Time (hours:minutes) [ Time Frame: 24 hours ]Another secondary objective is to assess the time to first ambulation as measured in hours:minutes after the end of surgery.
- Oral Intake Time (hours:minutes) [ Time Frame: 24 hours ]Another secondary objective is to assess the time to first oral intake as measured in hours:minutes after the end of surgery.
- Discharge Readiness Time (hours:minutes) [ Time Frame: 72 hours ]Another secondary objective is to assess the time time for discharge readiness as measured in hours:minutes after the end of surgery.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Study population is for hysterectomy (surgical removal of the uterus) which is only present in female patients|
|Accepts Healthy Volunteers:||Yes|
- Female ASA physical status 1-3 scheduled for open abdominal hysterectomy
- Age 18-80 years old
- Able to participate personally or by legal representative in informed consent in English or Spanish
- History of relevant drug allergy
- Age less than 18 or greater than 80 years
- Chronic opioid use or drug abuse
- Active use of anticoagulant medication
- Significant psychiatric disturbance
- Inability to understand the study protocol
- Refusal to provide written consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074226
|Contact: Farzin Ahmedemail@example.com|
|Contact: Emily Melikmanfirstname.lastname@example.org|
|United States, Texas|
|Parkland Health and Hospital System||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: John C Alexander, MD, MBA 469-419-1510 John.Alexander@UTSouthwestern.edu|
|Contact: Irina Gasanova, MD, Phd 4694191997 Irina.Gasanova@utsouthwestern.edu|
|Principal Investigator: John C Alexander, MD,MBA|
|Principal Investigator:||John C Alexander, MD||UT Southwestern|
|Responsible Party:||John Alexander, Associate Professor, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 30, 2019 Key Record Dates|
|Last Update Posted:||April 14, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Individual Participant Data will not be shared|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
erector spinae plane block
quadratus lumborum block