Clinical trial NCT06298227: Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy
Official title: The Comparison of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Nephrectomy: A Randomized, Prospective, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Diseases
Kidney Failure
Keywords: Laparoscopic nephrectomy
Postoperative pain management
Erector spinae plane block
Quadratus lumborum block
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic nephrectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group ESPB = ESPB group, Group QLB = QLB group) including 30 patients each, before entering the operating room.
Primary purpose: TREATMENT

Brief summary: Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.

US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.

This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

Detailed description: Nephrectomy for renal transplantation is a commonly performed procedure. The laparoscopic live donor nephrectomy (LLDN) is associated with many benefits and has become the gold standard for kidney retrieval surgery. As compared to open donor nephrectomy (ODN), LLDN has been shown to have less post-operative pain, shorter hospital stays, and faster recovery. Even though LLDN is less traumatic, some patients undergoing laparoscopic live donor nephrectomy still suffer significant postoperative pain require parenteral opioids, and have a risk for chronic pain.

The postoperative pain mechanism of LLDN is multifactorial - port pain, pain caused by incisions to retrieve the kidney, pelvic organ nociception, diaphragmatic irritation, and discomfort of a urinary catheter. Opioids, epidural anesthesia, Transversus Abdominal Plane (TAP) Block, and local infiltration of local anesthetics are used to prevent postoperative pain after LLDN.

In this study, the investigators aim to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for living donor laparoscopic nephrectomy under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis,
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who refuse the procedure or participation in the study

Primary outcomes:
measure: Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively
timeFrame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary outcomes:
measure: Pain scores (Numerical rating scale-NRS)
timeFrame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
measure: Need for rescue analgesia (meperidine)
timeFrame: Postoperative 24 hours period
measure: Adverse events
timeFrame: Postoperative 24 hours period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Mega Hospital Complex
state: Bağcılar
Study officials:
References:
citation: Elsharkawy H, Ahuja S, Sessler DI, Maheshwari K, Mao G, Sakr Esa WA, Soliman LM, Ayad S, Khoshknabi D, Khan MZ, Raza S, DeGrande S, Turan A. Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Apr 1;132(4):1138-1145. doi: 10.1213/ANE.0000000000005382.
citation: Alvi AS, Nasir JA, Nizam MA, Hamdani MM, Bhangar NA, Sibtain SA, Lalani AS, Warle MC. Quadratus lumborum block and transversus abdominis plane block in laparoscopic nephrectomy: a meta-analysis. Pain Manag. 2023 Sep;13(9):555-567. doi: 10.2217/pmt-2023-0033. Epub 2023 Sep 18.
citation: Wang J, Chu T, Sun R, Xu A. Analgesic Efficacy of Quadratus Lumborum Block in Patients Undergoing Nephrectomy: A Systematic Review and Meta-Analysis. Pain Med. 2023 May 2;24(5):476-487. doi: 10.1093/pm/pnac166.
citation: Sahin A, Baran O. Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. J Int Med Res. 2022 Mar;50(3):3000605221086737. doi: 10.1177/03000605221086737.
citation: Fan Q, Liu H, Li Y, Dai H, Wang Y. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after laparoscopic nephrectomy: a randomized controlled non-inferiority clinical trial. Minerva Anestesiol. 2023 Jun;89(6):520-528. doi: 10.23736/S0375-9393.22.16794-5. Epub 2023 Jan 24.