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Clinical Trials/NCT05597683
NCT05597683
Recruiting
Not Applicable

Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial

Gangnam Severance Hospital1 site in 1 country50 target enrollmentNovember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cytoreductive Surgery
Sponsor
Gangnam Severance Hospital
Enrollment
50
Locations
1
Primary Endpoint
Total opioid consumption for 24 postoperative hours
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.

Detailed Description

Adult patients scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy will be screened for eligibility. After induction of general anesthesia, ultrasound-guided bilateral transmuscular quadratus lomborum block will be done in QL block group. 0.375% ropivacaine will be injected to each side. Patients in control group will receive no block. Multimodal analgesia will be applied to every patient for postoperative pain control. Multimodal analgesic regimen included scheduled administration of acetaminophen, NSAIDs, and rescue opioids. Blinded investigator will assess pain scores at rest and on movement at 6, 12, 24, 48, 72 hours after surgery, analgesic consumptions, nausea, vomiting, and quality of recovery questionnaire.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
January 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Song

Associate Professor

Gangnam Severance Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)

Exclusion Criteria

  • Allergy to local anesthetics or fentanyl
  • Chronic pain
  • Patients who are unable to use patient-controlled analgesia
  • Skin infection at site for quadratus lomborum block
  • pregnant or breatfeeding women
  • Patients who are unable to communicate

Outcomes

Primary Outcomes

Total opioid consumption for 24 postoperative hours

Time Frame: 24 hours postoperatively

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

Secondary Outcomes

  • Time to first rescue analgesics(within post-operative 24 hours)
  • Resting pain numeric rating scale(NRS)(at postoperative 6, 12, 24, 48, 72 hours)
  • Time to first ambulation(within post-operative 72 hours)
  • Rescue analgesics administration(within post-operative 48 hours)
  • The incidence of post-operative nausea and vomiting(within post-operative 72 hours)
  • Analgesic consumption(at postoperative 6, 12, 48, 72 hours)
  • Numeric rating scale of pain during movement(at postoperative 6, 12, 24, 48, 72 hours)
  • Quality of Recovery Questionnaire (15-item Quality of Recovery)(At post-operative 72 hours)
  • Numeric rating scale at post anesthetic care unit (PACU)(30 minutes after the end of operation)
  • Length of hospital stay(within postoperative 30 days)
  • Patient satisfaction with pain control(At post-operative 72 hours)
  • Pattern of injectate spread on ultrasonography(During quadratus lumborum (QL) block procedure)

Study Sites (1)

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