Quadratus Lumborum Block After Living Donor Kidney Transplantation

Analgesia Clinical Trial

Official title:

Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908761
• Other study ID #: 2104-083-1211
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: May 28, 2022

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 28, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

? Patients with skin diseases or infections in the area where quadratus lumborum block is applied

? Any other cases that researchers determine that it is inappropriate for this clinical trial

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic consumption for 24 postoperative hours	Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))	24 hours postoperatively
Secondary	Analgesic consumption	Analgesic consumption at postoperative 6, 12, 48 hours	at postoperative 6, 12, 48 hours
Secondary	Resting pain numeric rating scale(NRS)	Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48 hours. Numeric rating scare is 11-point scale from 0 to 10, The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).	at postoperative 6, 12, 24, 48 hours
Secondary	Numeric rating scale of pain during movement	Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48 hours Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).	at postoperative 6, 12, 24, 48 hours
Secondary	Time to first rescue analgesics	Time to first rescue analgesics	within post-operative 24 hours
Secondary	Numeric rating scale at post anesthetic care unit (PACU)	Numeric rating scale at post anesthetic care unit Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).	30 minutes after the end of operation
Secondary	Rescue analgesics administration	Rescue analgesics administration count	within post-operative 48 hours
Secondary	The incidence of post-operative nausea and vomiting	The incidence of post-operative nausea and vomiting	within post-operative 48 hours
Secondary	Patient satisfaction with pain control	Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction.	At post-operative 48 hours
Secondary	Pattern of injectate spread on ultrasonography	Pattern of injectate spread on ultrasonography	During procedure quadratus lumborum (QL) block
Secondary	Sensory blockade	After surgery, an alcohol swab is used to evaluate the loss of cold sensation. It is evaluated by dividing into nine regions bordering the rib margin on the side of the surgery, the horizontal line passing through the umbilicus and pubis, and the vertical line of the midclavicular line, anterior axillary line, and mid axillary line. If cold sensation is the same as the opposite part of the regions, marked as 2 points, if decreased marked as 1 point, and if not sensed at all, marked as 0 point.	30 minutes after the end of operation
Secondary	Quality of Recovery Questionnaire (15-item Quality of Recovery)	Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.	At post-operative 48 hours
Secondary	The severity of post-operative nausea and vomiting	The severity of post-operative nausea and vomiting, The severity of the nausea and vomitting is asked to patient and expressed as none, mild, or severe.	within post-operative 48 hours