Cytoreductive Surgery, Hyperthermic Intra-peritoneal Chemotherapy, Peritoneal Cancer
Conditions
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.
Interventions
PROCEDUREArm 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
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients, medical staff who measure outcome variables, and nurses in the recovery room are double-blinded so that medical staff and patients do not know the patient's assigned group.
Intervention model description
hyperthermic intra-peritoneal chemotherapy
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption for 24 postoperative hours | 24 hours postoperatively | Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | at postoperative 6, 12, 48, 72 hours | Analgesic consumption at postoperative 6, 12, 48, 72 hours |
| Resting pain numeric rating scale(NRS) | at postoperative 6, 12, 24, 48, 72 hours | Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours. |
| Numeric rating scale of pain during movement | at postoperative 6, 12, 24, 48, 72 hours | Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48, 72 hours |
| Rescue analgesics administration | within post-operative 48 hours | Rescue analgesics administration count |
| The incidence of post-operative nausea and vomiting | within post-operative 72 hours | The incidence of post-operative nausea and vomiting |
| Time to first rescue analgesics | within post-operative 24 hours | Time to first rescue analgesics |
| Quality of Recovery Questionnaire (15-item Quality of Recovery) | At post-operative 72 hours | 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. |
| Pattern of injectate spread on ultrasonography | During quadratus lumborum (QL) block procedure | Pattern of injectate spread on ultrasonography |
| Numeric rating scale at post anesthetic care unit (PACU) | 30 minutes after the end of operation | 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 to first ambulation | within post-operative 72 hours | Time to first ambulation |
| Length of hospital stay | within postoperative 30 days | Length of hospital stay |
| Patient satisfaction with pain control | At post-operative 72 hours | Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction |
Countries
South Korea
Contacts
Primary ContactSunKyung Park
Outcome results
None listed