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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cytoreductive Surgery, Hyperthermic Intra-peritoneal Chemotherapy, Peritoneal Cancer

Intervention / Treatment
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* Procedure: Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: hyperthermic intra-peritoneal chemotherapy
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL block group<br>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)<br>* 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<br>|
| No Intervention: Control group<br>QL block will be not performed. | |

What is the study measuring?
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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 |