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

Peritoneal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597683
• Other study ID #: 3-2022-0328
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: November 10, 2024

Study information

• Verified date: April 2023
• Source: Gangnam Severance Hospital
• Contact: SunKyung Park
• Phone: 82-2-2019-4601
• Email: mayskpark[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 10, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytoreductive Surgery
• Fever
• Hyperthermia
• Peritoneal Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid consumption for 24 postoperative hours	Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))	24 hours postoperatively
Secondary	Analgesic consumption	Analgesic consumption at postoperative 6, 12, 48, 72 hours	at postoperative 6, 12, 48, 72 hours
Secondary	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
Secondary	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
Secondary	Time to first rescue analgesics	Time to first rescue analgesics	within post-operative 24 hours
Secondary	Rescue analgesics administration	Rescue analgesics administration count	within post-operative 48 hours
Secondary	The incidence of post-operative nausea and vomiting	The incidence of post-operative nausea and vomiting	within post-operative 72 hours
Secondary	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
Secondary	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
Secondary	Pattern of injectate spread on ultrasonography	Pattern of injectate spread on ultrasonography	During quadratus lumborum (QL) block procedure
Secondary	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
Secondary	Time to first ambulation	Time to first ambulation	within post-operative 72 hours
Secondary	Length of hospital stay	Length of hospital stay	within postoperative 30 days