Quadratus Lumborum Block After Living Donor Kidney Transplantation

NCT04908761 | Completed DMC

• 1 other identifier: 2104-083-1211
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption for 24 postoperative hours

  Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))

  24 hours postoperatively

Secondary Outcomes (12)

• Analgesic consumption

  at postoperative 6, 12, 48 hours

• Resting pain numeric rating scale(NRS)

  at postoperative 6, 12, 24, 48 hours

• Numeric rating scale of pain during movement

  at postoperative 6, 12, 24, 48 hours

• Time to first rescue analgesics

  within post-operative 24 hours

• Numeric rating scale at post anesthetic care unit (PACU)

  30 minutes after the end of operation

Study Arms (2)

Transmuscular quadratus lumborum block group

EXPERIMENTAL

Patients assigned to the Transmuscular Quadratus Lumborum (TQL) block group receive the Transmuscular Quadratus Lumborum block in a lateral decubitus position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.

Procedure: Transmuscular quadratus lumborum block

Control group

PLACEBO COMPARATOR

For patients assigned to the control group, 30cc of 0.9% normal saline is used for Transmuscular Quadratus Lumborum block.

Procedure: Placebo

Interventions

Transmuscular quadratus lumborum block PROCEDURE

Patients assigned to the TQL block group receive the TQL block in a supine position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.

Transmuscular quadratus lumborum block group

Placebo PROCEDURE

For patients assigned to the control group, 30cc of 0.9% normal saline is used for TQL block.

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 19 years of age undergoing elective living donor kidney transplantation under general anesthesia in Seoul National University Hospital

You may not qualify if:

• Patients with severe pain before surgery
• Patients with a history hypersensitivity reactions on fentanyl or ropivacaine
• Patients who cannot maintain patient-controlled analgesia (PCA) by themselves
• ④ Patients with skin diseases or infections in the area where quadratus lumborum block is applied
• ⑤ Any other cases that researchers determine that it is inappropriate for this clinical trial

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (10)

• Yang P, Luo Y, Lin L, Zhang H, Liu Y, Li Y. The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial. Int J Surg. 2020 Jul;79:196-201. doi: 10.1016/j.ijsu.2020.05.073. Epub 2020 Jun 2.

  PMID: 32502705 BACKGROUND

• Territo A, Mottrie A, Abaza R, Rogers C, Menon M, Bhandari M, Ahlawat R, Breda A. Robotic kidney transplantation: current status and future perspectives. Minerva Urol Nefrol. 2017 Feb;69(1):5-13. doi: 10.23736/S0393-2249.16.02856-3. Epub 2016 Nov 30.

  PMID: 28009142 BACKGROUND

• Kruszyna T, Niekowal B, Krasnicka M, Sadowski J. Enhanced Recovery After Kidney Transplantation Surgery. Transplant Proc. 2016 Jun;48(5):1461-5. doi: 10.1016/j.transproceed.2015.11.037.

  PMID: 27496428 BACKGROUND

• Freir NM, Murphy C, Mugawar M, Linnane A, Cunningham AJ. Transversus abdominis plane block for analgesia in renal transplantation: a randomized controlled trial. Anesth Analg. 2012 Oct;115(4):953-7. doi: 10.1213/ANE.0b013e3182642117. Epub 2012 Jul 4.

  PMID: 22763899 BACKGROUND

• Rohan VS, Taber DJ, Patel N, Perez C, Pilch N, Parks S, Bolin E, Nadig SN, Baliga PK, Fleming JN. Impact of a multidisciplinary multimodal opioid minimization initiative in kidney transplant recipients. Clin Transplant. 2020 Oct;34(10):e14006. doi: 10.1111/ctr.14006. Epub 2020 Sep 4.

  PMID: 32524643 BACKGROUND

• de Boer HD, Detriche O, Forget P. Opioid-related side effects: Postoperative ileus, urinary retention, nausea and vomiting, and shivering. A review of the literature. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):499-504. doi: 10.1016/j.bpa.2017.07.002. Epub 2017 Jul 8.

  PMID: 29739538 BACKGROUND

• Jun JH, Kim GS, Lee JJ, Ko JS, Kim SJ, Jeon PH. Comparison of intrathecal morphine and surgical-site infusion of ropivacaine as adjuncts to intravenous patient-controlled analgesia in living-donor kidney transplant recipients. Singapore Med J. 2017 Nov;58(11):666-673. doi: 10.11622/smedj.2017077. Epub 2017 Aug 14.

  PMID: 28805236 BACKGROUND

• Korgvee A, Junttila E, Koskinen H, Huhtala H, Kalliomaki ML. Ultrasound-guided quadratus lumborum block for postoperative analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Feb 1;38(2):115-129. doi: 10.1097/EJA.0000000000001368.

  PMID: 33186305 BACKGROUND

• Uppal V, Retter S, Kehoe E, McKeen DM. Quadratus lumborum block for postoperative analgesia: a systematic review and meta-analysis. Can J Anaesth. 2020 Nov;67(11):1557-1575. doi: 10.1007/s12630-020-01793-3. Epub 2020 Aug 17.

  PMID: 32808097 BACKGROUND

• Kim Y, Kim JT, Yang SM, Kim WH, Han A, Ha J, Min S, Park SK. Anterior quadratus lumborum block for analgesia after living-donor renal transplantation: a double-blinded randomized controlled trial. Reg Anesth Pain Med. 2024 Aug 5;49(8):550-557. doi: 10.1136/rapm-2023-104788.

  PMID: 37704438 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sun-Kyung Park, M.D.,Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, medical staff who measure outcome variables, and nurses in the recovery room are double-blinded so that medical staff and patients do not know the patient's assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Single center, double-blind, randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 1, 2021
• Study Start: June 3, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 28, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)