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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SunKyung Park; Phone Number: 82-2-2019-4601; Email: mayskpark@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Sun Kyung Park; Phone Number: 82-2-2019-4601; Email: gsirb@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL block group; Bilateral transmuscular QL block will be performed under ultrasound-guidance. Twenty mililiter of 0.375% ropivacaine will be injected to each side.	Procedure: Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block); Arm I (QL block and multimodal analgesia): Bilateral transmuscular QL block will be done. Postoperative multimodal analgesia including administration of acetaminophen, NSAIDs,nefopam, and rescue opioids Arm II (multimodal analgesia without regional block): No block will be done. Postoperative multimodal analgesia including administration of acetaminophen, NSAIDs, nefopam, and rescue opioids
No Intervention: Control group; QL block will be not performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption for 24 postoperative hours	Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic consumption	Analgesic consumption at postoperative 6, 12, 48, 72 hours	at postoperative 6, 12, 48, 72 hours
Resting pain numeric rating scale(NRS)	Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours.	at postoperative 6, 12, 24, 48, 72 hours
Numeric rating scale of pain during movement	Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48, 72 hours	at postoperative 6, 12, 24, 48, 72 hours
Time to first rescue analgesics	Time to first rescue analgesics	within post-operative 24 hours
Rescue analgesics administration	Rescue analgesics administration count	within post-operative 48 hours
The incidence of post-operative nausea and vomiting	The incidence of post-operative nausea and vomiting	within post-operative 72 hours
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 72 hours
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 72 hours
Pattern of injectate spread on ultrasonography	Pattern of injectate spread on ultrasonography	During quadratus lumborum (QL) block procedure
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
Time to first ambulation	Time to first ambulation	within post-operative 72 hours
Length of hospital stay	Length of hospital stay	within postoperative 30 days

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Young Song, Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): November 10, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: 3-2022-0328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No