Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block).
- Who it may be relevant to
- Registry conditions: Cytoreductive Surgery, Hyperthermic Intra-peritoneal Chemotherapy, Peritoneal Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial
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.
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.
Interventions
- 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
Primary outcome measures
- Total opioid consumption for 24 postoperative hours [Time frame: 24 hours postoperatively]
Secondary outcome measures (12)
- Analgesic consumption [Time frame: at postoperative 6, 12, 48, 72 hours]
- Resting pain numeric rating scale(NRS) [Time frame: at postoperative 6, 12, 24, 48, 72 hours]
- Numeric rating scale of pain during movement [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 [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 [Time frame: At post-operative 72 hours]
- Quality of Recovery Questionnaire (15-item 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) [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Gangnam Severance Hospital — Seoul
Identifiers
NCT: NCT05597683 · 3-2022-0328