ESP vs QL for Total Abdominal Hysterectomy

• ClinicalTrials.gov Identifier: NCT04074226
• Recruitment Status: Terminated
• First Posted: August 30, 2019
• Last Update Posted: April 4, 2023
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): John Alexander, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: July 26, 2019
• First Posted Date: August 30, 2019
• Last Update Posted Date: April 4, 2023
• Actual Study Start Date: March 20, 2021
• Actual Primary Completion Date: March 20, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 26, 2019)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ESP vs QL for Total Abdominal Hysterectomy
• 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

Brief 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.

Detailed Description

The investigators will study 82 American Society of Anesthesiologists (ASA) physical status 1-3 subjects scheduled for open Total Abdominal Hysterectomy who will be identified by anesthesia providers during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment at Parkland Hospital. If the subjects agree to participate in the study, the researchers will determine eligibility. If the subject meets all inclusion/exclusion criteria, the subject will be asked to sign the Consent Form and HIPAA Authorization Form prior to any study procedures in a face-to-face meeting with the researchers.

Protected patient information will include name, medical record number, date of birth, and contact information including telephone number. Height and weight will also be recorded. All patients will receive a standardized general anesthetic based on Enhanced Recovery After Surgery protocols. One of the investigators will randomly allocate patients using computer generated randomization schedule to one of the two groups.

Study Groups:

Group 1: Ultrasound-guided ESP block with liposomal bupivacaine

Group 2: Ultrasound-guided QL block with liposomal bupivacaine.

Anesthesiologists with previous experience in ultrasound-guided regional anesthesia procedures will perform the block based on randomization results. In both groups the patient will be placed in a sitting position, a SonoSite X-Porte linear ultrasound transducer will be used for real-time ultrasound guidance.

Group 1: 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.

Group 2: 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.

A standard postoperative analgesic regimen in both groups will include acetaminophen 1000 mg, orally every 8 hours and meloxicam 15mg, orally every 24 hours. For breakthrough pain (or rescue), immediate-release oxycodone 5-10mg, orally every 4 hours as needed for pain will be provided.

The efficacy of postoperative analgesia will be documented in all patients using the visual analog score (0=no pain, 10=worst pain). In addition, total morphine 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 antiemetics will be given to any patient who complains of nausea or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours postoperatively by an investigator blinded to group allocation.

For each patient the following data will be recorded:

Preoperatively:

• Age
• Gender
• Height
• Weight
• Baseline pain score
• Pre-operative block procedure, duration, amount of analgesia used
• Time to perform the blocks

Intraoperatively:

• Surgical time

Postoperatively:

• Post-Anesthesia Care Unit time
• Post-operative pain scores at 4, 6, 12, 24, 48, 72 hours
• cumulative opioid consumption during the first 24-hours postoperatively
• Time to first ambulation
• Time to first oral intake
• Time to be ready for discharge home

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
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

Primary Purpose: Treatment

• Condition: Postoperative Pain

Intervention

• 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

Study Arms

• 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.
  Intervention: Procedure: Erector Spinae Plane block
• 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.
  Intervention: Procedure: Quadratus Lumborum Block

Publications *

• Elsharkawy H, Bajracharya GR, El-Boghdadly K, Drake RL, Mariano ER. Comparing two posterior quadratus lumborum block approaches with low thoracic erector spinae plane block: an anatomic study. Reg Anesth Pain Med. 2019 Mar 28:rapm-2018-100147. doi: 10.1136/rapm-2018-100147. Online ahead of print.
• Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 31, 2023): 17
• Original Estimated Enrollment (submitted: August 26, 2019): 82
• Actual Study Completion Date: March 21, 2023
• Actual Primary Completion Date: March 20, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• 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

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04074226
• Other Study ID Numbers: STU-2019-1174
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individual Participant Data will not be shared

• Current Responsible Party: John Alexander, University of Texas Southwestern Medical Center
• Original Responsible Party: University of Texas Southwestern Medical Center
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: John C Alexander, MD; UT Southwestern

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: March 2023