Clinical trial NCT04908761: Quadratus Lumborum Block After Living Donor Kidney Transplantation
Official title: Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, double-blind, randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesic consumption for 24 postoperative hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Analgesic consumption
timeFrame: at postoperative 6, 12, 48 hours
measure: Resting pain numeric rating scale(NRS)
timeFrame: at postoperative 6, 12, 24, 48 hours
measure: Numeric rating scale of pain during movement
timeFrame: at postoperative 6, 12, 24, 48 hours
measure: Time to first rescue analgesics
timeFrame: within post-operative 24 hours
measure: Numeric rating scale at post anesthetic care unit (PACU)
timeFrame: 30 minutes after the end of operation
measure: Rescue analgesics administration
timeFrame: within post-operative 48 hours
measure: The incidence of post-operative nausea and vomiting
timeFrame: within post-operative 48 hours
measure: Patient satisfaction with pain control
timeFrame: At post-operative 48 hours
measure: Pattern of injectate spread on ultrasonography
timeFrame: During procedure quadratus lumborum (QL) block
measure: Sensory blockade
timeFrame: 30 minutes after the end of operation
measure: Quality of Recovery Questionnaire (15-item Quality of Recovery)
timeFrame: At post-operative 48 hours
measure: The severity of post-operative nausea and vomiting
timeFrame: within post-operative 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sun-Kyung Park, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.