Cytoreductive SurgeryNCT05597683
Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
A study testing Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block) in people with Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cytoreductive Surgery, Hyperthermic Intra-peritoneal Chemotherapy, Peritoneal Cancer
- What is being tested?
- Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Sun Kyung Park, 82-2-2019-4601, gsirb@yuhs.ac
About this study
Official title: Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled 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.
Read the 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.
- Being tested
- Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| QL block group | Experimental | Bilateral transmuscular QL block will be performed under ultrasound-guidance. Twenty mililiter of 0.375% ropivacaine will be injected to each side. Receives: Procedure: Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block) |
| Control group | No intervention | QL block will be not performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption for 24 postoperative hours
Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
Measured: 24 hours postoperatively
Secondary outcomes (12)
Analgesic consumption
Analgesic consumption at postoperative 6, 12, 48, 72 hours
Measured: 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.
Measured: 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
Measured: at postoperative 6, 12, 24, 48, 72 hours
Time to first rescue analgesics
Time to first rescue analgesics
Measured: within post-operative 24 hours
Rescue analgesics administration
Rescue analgesics administration count
Measured: within post-operative 48 hours
The incidence of post-operative nausea and vomiting
The incidence of post-operative nausea and vomiting
Measured: within post-operative 72 hours
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
Measured: At post-operative 72 hours
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.
Measured: At post-operative 72 hours
Pattern of injectate spread on ultrasonography
Pattern of injectate spread on ultrasonography
Measured: During quadratus lumborum (QL) block procedure
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).
Measured: 30 minutes after the end of operation
Time to first ambulation
Time to first ambulation
Measured: within post-operative 72 hours
Length of hospital stay
Length of hospital stay
Measured: within postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start15 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytoreductive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hyperthermic intra-peritoneal chemotherapy
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
- Investigators
- Young Song, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597683
- Sponsor's protocol ID
- 3-2022-0328
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05597683
- Acronym / sponsor ID
- 3-2022-0328
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- hyperthermic intra-peritoneal chemotherapy
| Arm | Type | Receives |
|---|---|---|
| QL block group | Experimental | Procedure: Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)Bilateral transmuscular QL block will be performed under ultrasound-guidance. Twenty mililiter of 0.375% ropivacaine will be injected to each side. |
| Control group | No intervention | –QL block will be not performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | QL block group |
Primary outcome
Total opioid consumption for 24 postoperative hours
Time frame: 24 hours postoperatively
Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
12 secondary outcomes
Analgesic consumption
Time frame: at postoperative 6, 12, 48, 72 hours
Resting pain numeric rating scale(NRS)
Time frame: at postoperative 6, 12, 24, 48, 72 hours
Numeric rating scale of pain during movement
Time frame: at postoperative 6, 12, 24, 48, 72 hours
Time to first rescue analgesics
Time frame: within post-operative 24 hours
Rescue analgesics administration
Time frame: within post-operative 48 hours
The incidence of post-operative nausea and vomiting
Time frame: within post-operative 72 hours
Patient satisfaction with pain control
Time frame: At post-operative 72 hours
Quality of Recovery Questionnaire (15-item Quality of Recovery)
Time frame: At post-operative 72 hours
Pattern of injectate spread on ultrasonography
Time frame: During quadratus lumborum (QL) block procedure
Numeric rating scale at post anesthetic care unit (PACU)
Time frame: 30 minutes after the end of operation
Time to first ambulation
Time frame: within post-operative 72 hours
Length of hospital stay
Time frame: within postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Song principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block) in people with Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SunKyung Park (82-2-2019-4601, mayskpark@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption for 24 postoperative hours (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.