- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998954
QLESP Block in Hip Surgery
November 6, 2023 updated by: Xi Wu, Huazhong University of Science and Technology
QLESP Block for Postoperative Analgesia in Hip Surgery
Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain.
Regional analgesia techniques are critical components of an optimal multimodal analgesia technique for THA, as they have been shown to improve pain relief as well as reduce opioid requirements.
Ultrasound-guided suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option for THA.
However, SFI block may lead to decreased motor strength of the surgical limb thereby hindering postoperative mobilization.
Recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block.
In this randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component of non-opioid analgesic regimen in patients undergoing THA.
The primary outcome of the study was postoperative sufentanil consumption within the initial 24-h postoperative period after THA.
The secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
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
-
-
Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Union Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a posterolateral approach 5. Informed consent
Exclusion Criteria:
- 1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders or language barrier 3. Analgesics intake, history of substance abuse 4. Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe liver failure
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)
The patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the flank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle.
The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process.
The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration.
|
Fifteen ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process.
Fifteen ml of 0.375% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles.
|
|
Active Comparator: Suprainguinal fascia iliaca block (SFI group)
With the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine.
Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified.
With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle.
|
Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The cumulative opioid consumption
Time Frame: At 24 postoperative hours
|
At 24 postoperative hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative hospital length of stay
Time Frame: Up to 6 weeks
|
Up to 6 weeks
|
|
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time Frame: At 1, 6, 12, 24, and 48 hours after the surgery
|
At 1, 6, 12, 24, and 48 hours after the surgery
|
|
Quadriceps strength
Time Frame: At 1, 6, 12, 24, and 48 hours after the surgery
|
At 1, 6, 12, 24, and 48 hours after the surgery
|
|
The time to first rescue analgesia
Time Frame: Within postoperative 48 hours
|
Within postoperative 48 hours
|
|
The Time to Ambulation
Time Frame: Postoperative 48 hours
|
Postoperative 48 hours
|
|
Adverse events
Time Frame: Postoperative 48 hours
|
Postoperative 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xi Wu, Huazhong University of Science and Technology
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.
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)
August 22, 2023
Primary Completion (Estimated)
August 20, 2024
Study Completion (Estimated)
October 20, 2024
Study Registration Dates
First Submitted
August 13, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH20230812
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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