Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy

Not Applicable

Recruiting

• Conditions: Cytoreductive Surgery; Peritoneal Cancer; Hyperthermic Intra-peritoneal Chemotherapy
• Interventions: Procedure: Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)

• Registration Number: NCT05597683
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Study Start: 2022-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

1. Allergy to local anesthetics or fentanyl
2. Chronic pain
3. Drug abuse
4. Patients who are unable to use patient-controlled analgesia
5. Skin infection at site for quadratus lomborum block
6. pregnant or breatfeeding women
7. Patients who are unable to communicate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL block group	Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)	Bilateral transmuscular QL block will be performed under ultrasound-guidance. Twenty mililiter of 0.375% ropivacaine will be injected to each side.

Primary Outcome Measures

Name	Time	Method
Total opioid consumption for 24 postoperative hours	24 hours postoperatively	Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))

Secondary Outcome Measures

Name	Time	Method
Time to first rescue analgesics	within post-operative 24 hours	Time to first rescue analgesics
Resting pain numeric rating scale(NRS)	at postoperative 6, 12, 24, 48, 72 hours	Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours.
Time to first ambulation	within post-operative 72 hours	Time to first ambulation
Rescue analgesics administration	within post-operative 48 hours	Rescue analgesics administration count
The incidence of post-operative nausea and vomiting	within post-operative 72 hours	The incidence of post-operative nausea and vomiting
Analgesic consumption	at postoperative 6, 12, 48, 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	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	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.
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).
Length of hospital stay	within postoperative 30 days	Length of hospital stay
Patient satisfaction with pain control	At post-operative 72 hours	Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction
Pattern of injectate spread on ultrasonography	During quadratus lumborum (QL) block procedure	Pattern of injectate spread on ultrasonography

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of