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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05556759
Other study ID # 9721-18-9-2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2022
Est. completion date May 1, 2024

Study information

Verified date July 2023
Source Zagazig University
Contact Shereen E Abd Ellatif, MD
Phone 01007948840
Email shosh.again@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date May 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
control
patient will be operated under general anesthesia
IPS
patients will receive ultrasound-guided anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Supra-iliac QL
patients will receive ultrasound-guided supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Locations

Country Name City State
Egypt Faculty of medicine, zagazig university Zagazig Alsharqia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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.

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.

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary changes in Visual analogue scale (VAS)score On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
Secondary Total dose of rescue analgesia once the VAS score will be = 3, rescue analgesia in the form of 1 µg/kg fentanyl will be given and the total dose consumed will be recorded in the first 24 hours postoperatively
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