Kidney Diseases, Kidney Failure
Conditions
Keywords
Laparoscopic nephrectomy, Postoperative pain management, Erector spinae plane block, Quadratus lumborum block
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.
Interventions
OTHERPostoperative analgesia management with Paracerol® and IV PCA with Talinat®
In the postoperative period, 1 g of acetaminophen (Paracerol®) will be administered intravenously to patients every 8 hours. Patients in all groups will have IV patient-controlled analgesia (PCA- CADD-Solis®) containing 10 mcg/ml fentanyl ( Talinat®). 10 mcg bolus without infusion dose, 20-minute lock time will be the protocol. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®) will be administered as a rescue analgesic.
OTHERErector spinae plane block
The block will be applied while the patient is in the lateral decubitus position. The convex probe of US ( GE Healthcare®) will be placed longitudinally 4 cm lateral to the T11 transverse process. The erector spinae muscle and the hyperechoic transverse process will be visualized. Using the in-plane technique, the 100 mm block needle (Stimuplex 360®) will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block location. Once the block location is confirmed, 40 ml of 0.25% bupivacaine (Marcaine®) will be administered.
QLB will be performed with the patient in the lateral decubitus position. The convex probe of US ( GE Healthcare®) will be placed at the level of the 12th rib, just above the iliac crest, in the parasagittal oblique plane, at the L1-L2 level. After the quadratus lumborum, erector spinae, and psoas major muscles are visualized, a 100 mm block needle (Stimuplex 360®) will be advanced in-plane anteriorly to QL, and the needle tip will be brought between the QL and PM muscles (Anterior QLB). The location will be confirmed by hydraulic dissection with 5 ml saline injection. After the block location is confirmed, 40 ml of 0.25% bupivacaine (Marcaine®) will be administered.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes assessor and participants will be blinded to the study
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively | Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours. | The primary aim is to compare postoperative opioid consumption from the PCA device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (Numerical rating scale-NRS) | Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours | The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded |
| Need for rescue analgesia (meperidine) | Postoperative 24 hours period | The secondary aim is to compare rescue analgesia used in the postoperative 24 h. |
| Adverse events | Postoperative 24 hours period | The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAyşe İnce, Assist Prof, MD
Outcome results
None listed