QLESP Block for Pain Control in Robotic Partial Nephrectomy
Ultrasound-Guided L2 Level QLESP Block for Postoperative Analgesia in Robot-Assisted Partial Nephrectomy: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to learn if an ultrasound-guided nerve block called QLESP works to reduce pain and the need for strong pain medicines after robotic kidney surgery in adults. The main questions it aims to answer are:
- Does QLESP reduce the total amount of opioid pain medicine participants need in the first 48 hours after surgery?
- Does QLESP lower pain scores and improve recovery quality after surgery? Researchers will compare participants who receive QLESP block to participants who receive the same numbing medicine injected only at the surgical wound sites.
Participants will:
- Be randomly assigned to receive either QLESP or local wound injection before surgery.
- Have a patient-controlled pain pump for 48 hours after surgery.
- Complete pain scores and recovery quality questionnaires at 2, 6, 12, 24, 48, and 72 hours after surgery.
- Be followed until hospital discharge.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Xi Wu
- Phone Number: +8615871715431
- Email: wu2018whuh@163.com
Study Locations
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Hubei
-
Wuhan, Hubei, China, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- You-nian Xu
- Phone Number: +8613657263415
- Email: xyn0103@hust.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 to 75 years
- Scheduled for elective robot-assisted partial nephrectomy (RAPN)
- American Society of Anesthesiologists (ASA) physical status I to III
- Body mass index (BMI) 18 to 35 kg/m²
- Voluntarily signed informed consent form Able to understand pain scoring and use of patient-controlled analgesia (PCA)
Exclusion Criteria:
- Language, communication, or comprehension barriers
- Infection at the intended puncture site
- Coagulopathy or bleeding diathesis
- Known allergy or contraindication to local anesthetics or opioids
- Use of analgesic medications within the past 3 months
- Peripheral neuropathy
- Severe cardiac, hepatic, or renal dysfunction
- Pregnancy or breastfeeding
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: QLESP Group
Participants receive ultrasound-guided QLESP block with 30 mL of 0.375% ropivacaine (15 mL in the erector spinae fascial plane and 15 mL in the quadratus lumborum-psoas major interfascial plane) after induction of general anesthesia.
|
Local wound infiltration with 30 mL of 0.375% ropivacaine at the port sites performed by the surgeon at the end of surgery.
|
|
Active Comparator: Control Group
Participants receive local wound infiltration with 30 mL of 0.375% ropivacaine at the port sites performed by the surgeon at the end of surgery.
|
Ultrasound-guided QLESP block with 30 mL of 0.375% ropivacaine (15 mL injected between the erector spinae muscle and the transverse process at L2 level, followed by 15 mL injected between the quadratus lumborum and psoas major muscles) after induction of general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Opioid Consumption at 48 Hours Postoperatively
Time Frame: From the end of surgery to 48 hours postoperatively.
|
Cumulative opioid consumption measured at 48 hours after surgery
|
From the end of surgery to 48 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Elsharkawy H, Bajracharya GR, El-Boghdadly K, Drake RL, Mariano ER. Comparing two posterior quadratus lumborum block approaches with low thoracic erector spinae plane block: an anatomic study. Reg Anesth Pain Med. 2019 Mar 28:rapm-2018-100147. doi: 10.1136/rapm-2018-100147. Online ahead of print.
- Kadam VR, Van Wijk RM, Ludbrook GL, Thiruvenkatarajan V. Anatomical and ultrasound description of two transmuscular quadratus lumborum block approaches at L2 level and their application in abdominal surgery. Anaesth Intensive Care. 2019 Mar;47(2):141-145. doi: 10.1177/0310057X19839931. Epub 2019 May 15.
- Little C, Rahman S. Quadratus Lumborum Blocks in Nephrectomy: A Narrative Review. Local Reg Anesth. 2021 Apr 19;14:57-65. doi: 10.2147/LRA.S290224. eCollection 2021.
- He Y, Huang M, Zhong Q, Ni H, Yu Z, Zhang X. Analgesic Effect of Ultrasound-Guided Anterior Quadratus Lumborum Block at the L2 Level in Patients Undergoing Laparoscopic Partial Nephrectomy: A Single-Center, Randomized Controlled Trial. Pain Res Manag. 2022 Dec 15;2022:8958859. doi: 10.1155/2022/8958859. eCollection 2022.
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Carcinoma
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Organic Chemicals
- Anilides
- Amides
- Aniline Compounds
- Amines
- Ropivacaine
Other Study ID Numbers
Other Study ID Numbers
- WHUH20260711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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