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

NCT05597683 | Recruiting

• 1 other identifier: 3-2022-0328
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytoreductive Surgery; Hyperthermic Intra-peritoneal Chemotherapy; Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption for 24 postoperative hours

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

  24 hours postoperatively

Secondary Outcomes (12)

• Analgesic consumption

  at postoperative 6, 12, 48, 72 hours

• Resting pain numeric rating scale(NRS)

  at postoperative 6, 12, 24, 48, 72 hours

• Numeric rating scale of pain during movement

  at postoperative 6, 12, 24, 48, 72 hours

• Time to first rescue analgesics

  within post-operative 24 hours

• Rescue analgesics administration

  within post-operative 48 hours

Study Arms (2)

QL block group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

QL block will be not performed.

Interventions

Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block) PROCEDURE

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

QL block group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy to local anesthetics or fentanyl
• Chronic pain
• Drug abuse
• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Young Song

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SunKyung Park

CONTACT

82-2-2019-4601; mayskpark@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: hyperthermic intra-peritoneal chemotherapy

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: November 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 10, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)