Clinical trial NCT05465967: Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
Official title: A Comparative Study Between Two Approaches of Ultrasound-Guided Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quadratus Lumborum Block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery.

Detailed description: During the preanesthetic assessment, all patients will be educated about the visual analogue scale (VAS) for pain assessment, with scores ranging from 0 to 10 (0 represent no pain, while10 represent maximum intolerable pain).

The patients will be randomly classified into three equal groups (25 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and postoperative assessor will be blinded to group assignment.

Patients will be randomized to one of three equal groups:

* Group I: Control group (n= 25 patients): Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.
* Group II (n= 25 patients): Patients in this group will receive an ipsilateral single shot of transverse transmuscular approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
* Group III (n= 25 patients): patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Eligibility criteria: Inclusion Criteria:

* 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery.

Exclusion Criteria:

* Patient refusal.
* Coagulopathy
* Spinal deformities
* Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain.
* Mental dysfunction, psychiatric illnesses and cognitive dysfunction.
* History of drug abuse \&chronic analgesic use

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: Baseline
Secondary outcomes:
measure: Postoperative pain score
timeFrame: Baseline
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanata university hospital
Study officials:
affiliation: TANYAU
name: YASSER M RAGHEB, PROF
role: STUDY_CHAIR
References:
citation: Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.
citation: Abduallah MA, Ahmed SA, Abdelghany MS. The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study. Indian J Anaesth. 2020 Oct;64(10):887-893. doi: 10.4103/ija.IJA_275_20. Epub 2020 Oct 1.