Clinical trial NCT05597683: Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
Official title: Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cytoreductive Surgery
Hyperthermic Intra-peritoneal Chemotherapy
Peritoneal Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hyperthermic intra-peritoneal chemotherapy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total opioid consumption for 24 postoperative hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Analgesic consumption
timeFrame: at postoperative 6, 12, 48, 72 hours
measure: Resting pain numeric rating scale(NRS)
timeFrame: at postoperative 6, 12, 24, 48, 72 hours
measure: Numeric rating scale of pain during movement
timeFrame: at postoperative 6, 12, 24, 48, 72 hours
measure: Time to first rescue analgesics
timeFrame: within post-operative 24 hours
measure: Rescue analgesics administration
timeFrame: within post-operative 48 hours
measure: The incidence of post-operative nausea and vomiting
timeFrame: within post-operative 72 hours
measure: Patient satisfaction with pain control
timeFrame: At post-operative 72 hours
measure: Quality of Recovery Questionnaire (15-item Quality of Recovery)
timeFrame: At post-operative 72 hours
measure: Pattern of injectate spread on ultrasonography
timeFrame: During quadratus lumborum (QL) block procedure
measure: Numeric rating scale at post anesthetic care unit (PACU)
timeFrame: 30 minutes after the end of operation
measure: Time to first ambulation
timeFrame: within post-operative 72 hours
measure: Length of hospital stay
timeFrame: within postoperative 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Young Song
role: PRINCIPAL_INVESTIGATOR
References: