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Quadratus Lumborum Block After Living Donor Kidney Transplantation

NCT ID: NCT04908761

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2022-05-28

Brief Summary

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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.

Detailed Description

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The purpose of this study was to investigate whether postoperative pain is significantly reduced when TQL block was additionally performed after surgery in patients undergoing living-donor kidney transplantation. Therefore, investigator hypothesized that the analgesic consumption for postoperative 24 hours will decrease in TQL group compared to the control group. For secondary outcomes, the pain score at rest/ movement up to 48 hours after surgery, the time until the first pain reliever is requested, whether and how often rescue analgesics are administered for 48 hours, the incidence and severity of nausea and vomiting during the 48 hours after surgery, patient's satisfaction with post-pain control and the number of hospital stays were investigated. Overall, the aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patients undergoing a living donor kidney transplantation under general anesthesia.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center, double-blind, randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Transmuscular quadratus lumborum block group

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.

Group Type EXPERIMENTAL

Transmuscular quadratus lumborum block

Intervention Type 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.

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

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

Interventions

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Transmuscular quadratus lumborum block

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.

Intervention Type PROCEDURE

Placebo

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sun-Kyung Park

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sun-Kyung Park, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 32502705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28009142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27496428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22763899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32524643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29739538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28805236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33186305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32808097 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37704438 (View on PubMed)

Other Identifiers

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2104-083-1211

Identifier Type: -

Identifier Source: org_study_id