Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
Primary Purpose
Cytoreductive Surgery, Hyperthermic Intra-peritoneal Chemotherapy, Peritoneal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)
Sponsored by
About this trial
This is an interventional treatment trial for Cytoreductive Surgery
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
Sites / Locations
- Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
QL block group
Control group
Arm Description
Bilateral transmuscular QL block will be performed under ultrasound-guidance. Twenty mililiter of 0.375% ropivacaine will be injected to each side.
QL block will be not performed.
Outcomes
Primary Outcome Measures
Total opioid consumption for 24 postoperative hours
Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
Secondary Outcome Measures
Analgesic consumption
Analgesic consumption at postoperative 6, 12, 48, 72 hours
Resting pain numeric rating scale(NRS)
Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours.
Numeric rating scale of pain during movement
Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48, 72 hours
Time to first rescue analgesics
Time to first rescue analgesics
Rescue analgesics administration
Rescue analgesics administration count
The incidence of post-operative nausea and vomiting
The incidence of post-operative nausea and vomiting
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
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.
Pattern of injectate spread on ultrasonography
Pattern of injectate spread on ultrasonography
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).
Time to first ambulation
Time to first ambulation
Length of hospital stay
Length of hospital stay
Full Information
NCT ID
NCT05597683
First Posted
October 25, 2022
Last Updated
April 21, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05597683
Brief Title
Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
Official Title
Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
November 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytoreductive Surgery, Hyperthermic Intra-peritoneal Chemotherapy, Peritoneal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
hyperthermic intra-peritoneal chemotherapy
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QL block group
Arm Type
Experimental
Arm Description
Bilateral transmuscular QL block will be performed under ultrasound-guidance. Twenty mililiter of 0.375% ropivacaine will be injected to each side.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
QL block will be not performed.
Intervention Type
Procedure
Intervention Name(s)
Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)
Intervention 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
Primary Outcome Measure Information:
Title
Total opioid consumption for 24 postoperative hours
Description
Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Analgesic consumption at postoperative 6, 12, 48, 72 hours
Time Frame
at postoperative 6, 12, 48, 72 hours
Title
Resting pain numeric rating scale(NRS)
Description
Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours.
Time Frame
at postoperative 6, 12, 24, 48, 72 hours
Title
Numeric rating scale of pain during movement
Description
Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48, 72 hours
Time Frame
at postoperative 6, 12, 24, 48, 72 hours
Title
Time to first rescue analgesics
Description
Time to first rescue analgesics
Time Frame
within post-operative 24 hours
Title
Rescue analgesics administration
Description
Rescue analgesics administration count
Time Frame
within post-operative 48 hours
Title
The incidence of post-operative nausea and vomiting
Description
The incidence of post-operative nausea and vomiting
Time Frame
within post-operative 72 hours
Title
Patient satisfaction with pain control
Description
Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction
Time Frame
At post-operative 72 hours
Title
Quality of Recovery Questionnaire (15-item Quality of Recovery)
Description
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.
Time Frame
At post-operative 72 hours
Title
Pattern of injectate spread on ultrasonography
Description
Pattern of injectate spread on ultrasonography
Time Frame
During quadratus lumborum (QL) block procedure
Title
Numeric rating scale at post anesthetic care unit (PACU)
Description
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 Frame
30 minutes after the end of operation
Title
Time to first ambulation
Description
Time to first ambulation
Time Frame
within post-operative 72 hours
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
within postoperative 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SunKyung Park
Phone
82-2-2019-4601
Email
mayskpark@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Song
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Kyung Park
Phone
82-2-2019-4601
Email
gsirb@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
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Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
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