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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05998954
Other study ID # XH20230812
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 22, 2023
Est. completion date October 20, 2024

Study information

Verified date November 2023
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 20, 2024
Est. primary completion date August 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block
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.
suprainguinal fascia iliaca block
Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.

Locations

Country Name City State
China Wuhan Union Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (1)

Wu X, Yang L. Quadratus Lumborum and modified Erector Spinae Plane (QLESP) block: A single-puncture technique for total hip arthroplasty. J Clin Anesth. 2020 May;61:109643. doi: 10.1016/j.jclinane.2019.109643. Epub 2019 Oct 23. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The cumulative opioid consumption At 24 postoperative hours
Secondary The pain scores determined by the numeric rating scale (NRS, 0-10) At 1, 6, 12, 24, and 48 hours after the surgery
Secondary Quadriceps strength At 1, 6, 12, 24, and 48 hours after the surgery
Secondary The time to first rescue analgesia Within postoperative 48 hours
Secondary Postoperative hospital length of stay Up to 6 weeks
Secondary The Time to Ambulation Postoperative 48 hours
Secondary Adverse events Postoperative 48 hours
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