Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Allergy to local anesthetics or fentanyl
Chronic pain
Drug abuse
Patients who are unable to use patient-controlled analgesia
Trial design
Design model
Parallel
Treatments tested in this trial
Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)
Procedure/SurgeryArm 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: QL block groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total opioid consumption for 24 postoperative hours
Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
Time frame
24 hours postoperativelySecondary outcomes
1
Analgesic consumption
Analgesic consumption at postoperative 6, 12, 48, 72 hours
Time frame
at postoperative 6, 12, 48, 72 hours2
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 hours3
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 hours4
Time to first rescue analgesics
Time to first rescue analgesics
Time frame
within post-operative 24 hoursSponsors and contacts
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Source ClinicalTrials.gov