Peritoneal Cancer Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gangnam Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04983550 -
Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC
|
Phase 2 | |
Completed |
NCT01610206 -
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
|
Phase 2 | |
Completed |
NCT00768144 -
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
|
Phase 2 | |
Completed |
NCT00801320 -
Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|
N/A | |
Suspended |
NCT00753480 -
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 1 | |
Recruiting |
NCT02349958 -
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy
|
Phase 2 | |
Completed |
NCT00268918 -
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
|
Phase 1 | |
Completed |
NCT00230542 -
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
|
Phase 2 | |
Completed |
NCT00461786 -
A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
|
Phase 2 | |
Terminated |
NCT00505661 -
Letrozole in Patients With Ovarian Tumors
|
Phase 2 | |
Completed |
NCT02865811 -
Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer
|
Phase 2 | |
Recruiting |
NCT05009082 -
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
|
Phase 3 | |
Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04907643 -
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
|
N/A | |
Completed |
NCT01891344 -
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
|
Phase 2 | |
Recruiting |
NCT05887609 -
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
|
Phase 2 | |
Active, not recruiting |
NCT02470299 -
Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients
|
N/A | |
Recruiting |
NCT06184867 -
Choices About Genetic Testing And Learning Your Risk With Smart Technology
|
Early Phase 1 | |
Recruiting |
NCT04516447 -
A Study of ZN-c3 in Patients With Ovarian Cancer
|
Phase 1 | |
Completed |
NCT04088786 -
Phase I Trial HIPEC With Nal-irinotecan
|
Phase 1 |