A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain
NCT ID: NCT04368364
Last Updated: 2022-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
3 participants
INTERVENTIONAL
2020-05-22
2020-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group 1 (Control group)
Intrathecal morphine sulfate (ITM)
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
Group 2(Bupivacaine hydrochloride group)
Bupivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
Group 3 (ropivacaine hydrochloride group)
ropivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Interventions
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Intrathecal morphine sulfate (ITM)
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
Bupivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
ropivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Living singleton pregnancy
* Gestation week at least 37 weeks
* American Society of Anesthesiologists (ASA) status 1, 2 and 3
* Primary and secondary C sections
Exclusion Criteria
* Opioid tolerant patients
* Allergy to drugs used in the study.
* Cognitive dysfunction
* BMI \> 40
* Coagulation disorder
* Local infection
* Inability to tolerate oral medication
* Previous intra-abdominal surgery
* Patients who will receive a combined spinal epidural for their C section
* Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
* Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
18 Years
FEMALE
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Sudipta Sen
Assistant Professor
Principal Investigators
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Sudipta Sen, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital TMC
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-20-0143
Identifier Type: -
Identifier Source: org_study_id
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