Quadratus Lumborum Block vs Erector Spinae Plane Block in Abdominal Hysterectomy

October 9, 2023 updated by: Onur Baran, Namik Kemal University

Ultrasound Guided Quadratus Lumborum Block Versus Erector Spinae Plane Block For Postoperative Analgesia In Patient Undergoing Abdominal Hysterectomy: A Randomized Double Blinded Study

Postoperative pain following abdominal hysterectomy is a challenging concern as some patients suffer acute pain that could let to chronic pain over time following the surgery. Epidural analgesia which is the gold standard for postoperative pain management in abdominal surgeries including abdominal hysterectomy has side effects such as hypotension, hematoma, motor weakness of lower limbs, paresthesia, intrathecal placement of the epidural catheter and urinary retention that could prolong hospital stay. Since high frequency ultrasound machines' usage has increased in postoperative analgesia management, ultrasound guided fascial plane blocks has been performed by clinicians with high success rate. To avoid possible complications of epidural catheter placement and epidural analgesia, various techniques has been applying for an analgesic effect close to the effectiveness of epidural analgesia. These techniques include transversus abdominis plane block, rectus sheath block, wound infiltration of local anesthetics, erector spinae plane block and quadratus lumborum plane block. However, each of the plane blocks has limitations individually which prevent them to be the unique analgesic technique for postoperative analgesia following abdominal surgery. As far as the authors knowledge, there's no reported study which compares ultrasound guided erector spinae plane block versus ultrasound guided quadratus lumborum type III block (anterior quadratus lumborum block) as a preemptive analgesia technique in patients undergoing abdominal hysterectomy.

Study Overview

Detailed Description

Hysterectomy is one of the most frequently performed surgical procedures in the United States. The management of postoperative pain in gynecologic surgery is challenging.

Due to side effects of opioids such as nausea and vomiting, titration of opioid dosage for postoperative pain is difficult and effective postoperative analgesic regimes is needed. Ultrasound guided regional anesthesia techniques such as erector spinae plane block and quadratus lumborum block for postoperative pain management has an acceleration in usage as ultrasound guidance makes the interventions safer and easier to perform, and they contribute to better pain control and pain experience. Ultrasound guided quadratus lumborum block for postoperative pain management after abdominal surgery was firstly conceived by Blanco in 26th European Society of Regional Anesthesia Congress in 2007 as a variant of transversus abdominis plane (TAP) block. Later on he reported posterior quadratus lumborum block (QLB) in 2013 which is known as QLB II. Børglum et. al described the transmuscular quadratus lumborum block (TQL or QLB III) in 2013 which is frequently performed in abdominal wall surgeries. QLB III, transmuscular quadratus lumborum block (TQL) and anterior quadratus lumborum block; these are all synonyms and refers to injection of local anesthetic into the anterior thoracolumbar fascia (TLF) which lays between quadratus lumborum muscle and psoas major muscle. Erector spinae plane block has being performed by clinicians for abdominal and thoracic surgeries since it was firstly described by Forero et al. in 2016 for analgesia in thoracic neuropathic pain. In this ultrasound guided technique local anesthetic is applied between the transverse process of the relevant thoracic or lumbar vertebrae and the erector spinae muscle which leads to the spread of the local anesthetic cephalad, caudally and through the paravertebral space. The investigators hypothesize that performing ultrasound-guided quadratus lumborum block will be more superior or equal to erector spinae plane block in providing postoperative analgesia for patients undergoing abdominal hysterectomy under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tekirdağ, Turkey
        • Tekirdag Namik Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who accepted to participate and signed written consent
  • Aged between 18 and 75
  • American Society of Anesthesiologists (ASA) physical score I or II
  • Elective abdominal hysterectomy operation

Exclusion Criteria:

  • Patients who declined to participate
  • BMI > 35 kg/m2
  • Uncontrolled systemic disease
  • <18 age and >75 age
  • Unable to cooperate (mental retardation)
  • Low cardiac capacity
  • Hypersensitivity history to the agents to be used
  • Coagulopathy
  • Local infections
  • Opioid addiction history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Patients will be operated under general anesthesia.
The patients will receive general anesthesia.
Other Names:
  • Control Group
Active Comparator: Quadratus Lumborum Block Group
Patients will receive ultrasound-guided quadratus lumborum block type III bilaterally with 30 ml of bupivacaine 0.25% on each side, totally 60 ml of bupivacaine 0.25% followed by general anesthesia.
Patients will receive ultrasound-guided quadratus lumborum block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
  • QLB III
Active Comparator: Erector Spinae Plane Block Group
Patients will receive ultrasound-guided erector spinae plane block bilaterally with 30 ml of bupivacaine 0.25% on each side, totally 60 ml of bupivacaine 0.25% followed by general anesthesia.
Patients will receive ultrasound-guided erector spinae plane block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
  • ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of opioid consumption (tramadol)
Time Frame: in the first 24 hour postoperatively
Total dose of tramadol consumption via patient controlled device
in the first 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
The 1st time to rescue analgesic need
Time Frame: recorded within the first 24 hour postoperatively
The time to ask for postoperative analgesia is the time from the end of operation to patient reporting Visual Analog Scale ≥ 4.
recorded within the first 24 hour postoperatively
Postoperative nausea and vomiting
Time Frame: recorded within the first 24 hour postoperatively
Postoperative nausea and vomiting presence
recorded within the first 24 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Onur Baran, Asst. Prof., Namik Kemal University
  • Principal Investigator: Ayhan Şahin, Asst. Prof., Namik Kemal University
  • Study Director: Cavidan Arar, Prof., Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

December 29, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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