Clinical trial NCT04005326: Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty
Official title: Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection.

This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.

Detailed description: A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry.

Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups:

QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative.

After finishing the block \& assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room.

Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours.

If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at \<3 with maximum total 24-hours morphine 10 mg.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

Exclusion Criteria:

* Coagulopathy, infection at the injection site,.
* Allergy to local anesthetics.
* Severe cardiopulmonary disease (≥ASA IV),.
* Diabetic or other neuropathies.
* Patients receiving opioids for chronic analgesic therapy.
* Contraindication to spinal anesthesia.
* Inability to comprehend visual analogue scale (VAS).

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Static visual analogue pain scale
timeFrame: 24 hours postoperative
measure: Dynamic visual analogue pain scale
timeFrame: 24 hours postoperative
measure: Onset of sensory block of quadratus lumborum block and fascia iliaca block
timeFrame: 30 minutes
measure: Time to first postoperative analgesic request
timeFrame: 24 hours postoperative
measure: Total morphine requirements
timeFrame: 24 hours postoperative
measure: Assessment of the quadriceps muscle power.
timeFrame: 24 hours
measure: Time needed to perform the block
timeFrame: 30 minutes
measure: incidence of pain during positioning for spinal block
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesia Department
Study officials:
affiliation: Cairo University
name: Ahmed M. Hasanin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bullock WM, Yalamuri SM, Gregory SH, Auyong DB, Grant SA. Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty. J Ultrasound Med. 2017 Feb;36(2):433-438. doi: 10.7863/ultra.16.03012. Epub 2016 Dec 10.
citation: Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
citation: Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
citation: Bang S, Chung J, Jeong J, Bak H, Kim D. Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine (Baltimore). 2016 Sep;95(39):e5018. doi: 10.1097/MD.0000000000005018.
citation: Nassar H, Hasanin A, Sewilam M, Ahmed H, Abo-Elsoud M, Taalab O, Rady A, Zoheir HA. Transmuscular Quadratus Lumborum Block versus Suprainguinal Fascia Iliaca Block for Hip Arthroplasty: A Randomized, Controlled Pilot Study. Local Reg Anesth. 2021 Apr 20;14:67-74. doi: 10.2147/LRA.S308964. eCollection 2021.