Quadratus Lumborum Block After Living Donor Kidney Transplantation

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04908761
Collaborator
(none)
90
1
2
10.2
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transmuscular quadratus lumborum block
  • Procedure: Placebo
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single center, double-blind, randomized controlled trialSingle center, double-blind, randomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial
Actual Study Start Date :
Jun 3, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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 Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

  1. Analgesic consumption for 24 postoperative hours [24 hours postoperatively]

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

Secondary Outcome Measures

  1. Analgesic consumption [at postoperative 6, 12, 48 hours]

    Analgesic consumption at postoperative 6, 12, 48 hours

  2. Resting pain numeric rating scale(NRS) [at postoperative 6, 12, 24, 48 hours]

    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).

  3. Numeric rating scale of pain during movement [at postoperative 6, 12, 24, 48 hours]

    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).

  4. Time to first rescue analgesics [within post-operative 24 hours]

    Time to first rescue analgesics

  5. Numeric rating scale at post anesthetic care unit (PACU) [30 minutes after the end of operation]

    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).

  6. Rescue analgesics administration [within post-operative 48 hours]

    Rescue analgesics administration count

  7. The incidence of post-operative nausea and vomiting [within post-operative 48 hours]

    The incidence of post-operative nausea and vomiting

  8. Patient satisfaction with pain control [At post-operative 48 hours]

    Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction.

  9. Pattern of injectate spread on ultrasonography [During procedure quadratus lumborum (QL) block]

    Pattern of injectate spread on ultrasonography

  10. Sensory blockade [30 minutes after the end of operation]

    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.

  11. Quality of Recovery Questionnaire (15-item Quality of Recovery) [At post-operative 48 hours]

    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.

  12. The severity of post-operative nausea and vomiting [within post-operative 48 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Sun-Kyung Park, M.D.,Ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sun-Kyung Park, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04908761
Other Study ID Numbers:
  • 2104-083-1211
First Posted:
Jun 1, 2021
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 4, 2022