Clinical trial NCT05556759: Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty
Official title: Anterior Iliopsoas Muscle Space Block Versus Supra-Iliac Anterior Quadratus Lumborum Block for Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Arthropathy
Keywords: Anterior iliopsoas muscle space block
suprailiac anterior quadratus lumborum block
analgesia
hip arthroplasty
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-09-27
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided randomly by a computer-generated randomization table into three groups:

Group C :(Control group) patients will be operated on under general anesthesia. Group IPS: patients will receive anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Group Supra-iliac QL: patients will receive supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Primary purpose: PREVENTION

Brief summary: Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, especially in the elderly, however, it is associated with moderate to severe postoperative pain.

Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesia techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components of enhanced recovery after surgery (ERAS).

Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local inﬁltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.

Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA under general anesthesia

Detailed description: The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. The lumbar (L1-L4) and sacral (L4-S4) plexuses both innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from the superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.

The lumbar plexus nerves, including the femoral, obturator, and lateral femoral cutaneous nerves, lie within the psoas major (PM) muscle. These nerves then exit the PM to lie within the iliopsoas compartment, between the iliacus and PM muscles. The sacral plexus is located also in the caudal extension of this anatomical space. The iliacus and psoas muscles are wrapped by the fascia iliaca. The fascia iliaca fuses superiorly with the anterior thoracolumbar fascia (transversalis fascia) that wrapped both the quadratus lumborum (QL) and the psoas muscles.

Total hip arthroplasty (THA) is a common orthopedic surgical procedure that has been successfully utilized to treat hip fractures since 1960 \[4\] as well, it is considered the treatment of choice for osteoarthritis of the hip joint. Both implants' types cemented and uncemented can provide good fixation, resulting in favorable long-term outcomes \[5\]. One of the keys to a patient's recovery following THA surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioids consumption and decreasing the time to mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, intrathecal morphine, fascia iliaca block, lumber plexus block, sacral plexus block, and local inﬁltration analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.

The ultrasound-guided (QL) block is a regional anesthetic technique that was initially proposed as an analgesic modality for abdominal surgery through many approaches: the lateral QL (QL1) block, the posterior QL (QL2) block, and the anterior QL (transmuscular) block The anterior QL block has been performed at the L3-L4 level also been used in hip surgery case reports.

A supra-iliac approach to the anterior QL block that is performed at a lower level than traditional anterior QL block approaches is considered a new approach discovered by Elsharkawy et al., and they found that a single injection between QL and Psoas muscle at the level of L5, successfully block the lumbar plexus and provide analgesia in patients undergoing total hip arthroplasty.

Anterior iliopsoas muscle space block is a new fascial block technique proposed by Dong et al., where the nerves of the lumbar plexus can be blocked by anterior injection in the iliopsoas space at the level of the anterior superior iliac spine and effectively provide perioperative analgesia for hip surgery.

This study will be designed to evaluate and compare the impact of these two fascial plane blocks for pre-emptive analgesia for patients undergoing total hip arthroplasty under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patient acceptance.
* Age 50-80 years old.
* BMI ≤ 30 kg/m2
* ASA I - III.
* Elective total hip arthroplasty under general anesthesia.

Exclusion Criteria:

* History of allergy to the LA agents used in this study
* Skin lesion at the needle insertion site,
* Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
* Pre-existing neurological deficit in the lower extremity
* History of chronic pain and taking analgesics
* History of cognitive dysfunction or mental illness

Primary outcomes:
measure: changes in Visual analogue scale (VAS)score
timeFrame: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
Secondary outcomes:
measure: Total dose of rescue analgesia
timeFrame: in the first 24 hours postoperatively
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, zagazig university
state: Alsharqia
Study officials:
affiliation: Faculty of medicine, zagazig university
name: Shereen E Abd Ellatif, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsharkawy H, El-Boghdadly K, Barnes TJ, Drake R, Maheshwari K, Soliman LM, Horn JL, Chin KJ. The supra-iliac anterior quadratus lumborum block: a cadaveric study and case series. Can J Anaesth. 2019 Aug;66(8):894-906. doi: 10.1007/s12630-019-01312-z. Epub 2019 Mar 11.
citation: Dong J, Zhang Y, Chen X, Ni W, Yan H, Liu Y, Shi H, Jiang W, Zhao D, Xu T. Ultrasound-guided anterior iliopsoas muscle space block versus posterior lumbar plexus block in hip surgery in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):366-373. doi: 10.1097/EJA.0000000000001452.
citation: Chalacheewa, T, Termpornlert, S, Sa-Ngasoongsong P, Sangkum, Lisa. Regional Anesthesia for Hip Surgery Patients: Review Article. Journal of the Medical Association of Thailand 2022; 105: 152-9.
citation: Dangle J, Kukreja P, Kalagara H. Review of Current Practices of Peripheral Nerve Blocks for Hip Fracture and Surgery. Curr Anesthesiol Rep 2020; 10:259-66.
citation: Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.