NCT06298227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

February 6, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

Laparoscopic nephrectomyPostoperative pain managementErector spinae plane blockQuadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively

    The primary aim is to compare postoperative opioid consumption from the PCA device.

    Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

Secondary Outcomes (3)

  • Pain scores (Numerical rating scale-NRS)

    Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours

  • Need for rescue analgesia (meperidine)

    Postoperative 24 hours period

  • Adverse events

    Postoperative 24 hours period

Study Arms (2)

Group ESPB = Erector spinae plane block group

ACTIVE COMPARATOR

ESPB will be performed

Other: Postoperative analgesia management with Paracerol® and IV PCA with Talinat®Other: Erector spinae plane block

Group QLB = Quadratus lumborum block group

ACTIVE COMPARATOR

QLB will be performed

Other: Postoperative analgesia management with Paracerol® and IV PCA with Talinat®Other: Quadratus lumborum plane block

Interventions

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.

Group ESPB = Erector spinae plane block groupGroup QLB = Quadratus lumborum block group

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.

Group ESPB = Erector spinae plane block group

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.

Group QLB = Quadratus lumborum block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Mega Hospital Complex

Istanbul, Bağcılar, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 33617181BACKGROUND
  • 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.

    PMID: 37718911BACKGROUND
  • 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.

    PMID: 36321993BACKGROUND
  • 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.

    PMID: 35301896BACKGROUND
  • 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.

    PMID: 36692339BACKGROUND

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Outcomes assessor and participants will be blinded to the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2024

First Posted

March 7, 2024

Study Start

March 11, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The investigators will not share individual patient data(IPD)

Locations