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

Gangnam Severance Hospital50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total opioid consumption for 24 postoperative hours

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

Time frame: 24 hours postoperatively

Secondary Outcomes

Analgesic consumption

Analgesic consumption at postoperative 6, 12, 48, 72 hours

Time frame: 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.

Time frame: 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

Time frame: at postoperative 6, 12, 24, 48, 72 hours

Time to first rescue analgesics

Time frame: within post-operative 24 hours

Rescue analgesics administration

Rescue analgesics administration count

Time frame: within post-operative 48 hours

The incidence of post-operative nausea and vomiting

Time frame: 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

Time frame: 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.

Time frame: At post-operative 72 hours

Pattern of injectate spread on ultrasonography

Time frame: 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).

Time frame: 30 minutes after the end of operation

Time to first ambulation

Time frame: within post-operative 72 hours

Length of hospital stay

Time frame: within postoperative 30 days