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Trial Title:
Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
NCT ID:
NCT05597683
Condition:
Cytoreductive Surgery
Hyperthermic Intra-peritoneal Chemotherapy
Peritoneal Cancer
Conditions: Official terms:
Hyperthermia
Fever
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
hyperthermic intra-peritoneal chemotherapy
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
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:
Intervention type:
Procedure
Intervention name:
Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)
Description:
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
Arm group label:
QL block group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun Kyung Park
Phone:
82-2-2019-4601
Email:
gsirb@yuhs.ac
Start date:
November 15, 2022
Completion date:
January 10, 2025
Lead sponsor:
Agency:
Gangnam Severance Hospital
Agency class:
Other
Source:
Gangnam Severance Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05597683
