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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05597683
Other study ID # 3-2022-0328
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date November 10, 2024

Study information

Verified date April 2023
Source Gangnam Severance Hospital
Contact SunKyung Park
Phone 82-2-2019-4601
Email mayskpark@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 10, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total opioid consumption for 24 postoperative hours Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME)) 24 hours postoperatively
Secondary Analgesic consumption Analgesic consumption at postoperative 6, 12, 48, 72 hours at postoperative 6, 12, 48, 72 hours
Secondary Resting pain numeric rating scale(NRS) Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours. at postoperative 6, 12, 24, 48, 72 hours
Secondary Numeric rating scale of pain during movement Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48, 72 hours at postoperative 6, 12, 24, 48, 72 hours
Secondary Time to first rescue analgesics Time to first rescue analgesics within post-operative 24 hours
Secondary Rescue analgesics administration Rescue analgesics administration count within post-operative 48 hours
Secondary The incidence of post-operative nausea and vomiting The incidence of post-operative nausea and vomiting within post-operative 72 hours
Secondary 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 At post-operative 72 hours
Secondary 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. At post-operative 72 hours
Secondary Pattern of injectate spread on ultrasonography Pattern of injectate spread on ultrasonography During quadratus lumborum (QL) block procedure
Secondary 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). 30 minutes after the end of operation
Secondary Time to first ambulation Time to first ambulation within post-operative 72 hours
Secondary Length of hospital stay Length of hospital stay within postoperative 30 days
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