NCT04368364
Terminated
Phase 4
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain
The University of Texas Health Science Center, Houston2 sites in 1 country3 target enrollmentMay 22, 2020
ConditionsPain, Postoperative
Overview
- Phase
- Phase 4
- Intervention
- Intrathecal morphine sulfate (ITM)
- Conditions
- Pain, Postoperative
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters
Investigators
Sudipta Sen
Assistant Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •Elective C section via Pfannenstiel incision
- •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
- •Chronic pain
- •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
Arms & Interventions
Group 1 (Control group)
Intervention: Intrathecal morphine sulfate (ITM)
Group 2(Bupivacaine hydrochloride group)
Intervention: Bupivacaine hydrochloride
Group 3 (ropivacaine hydrochloride group)
Intervention: ropivacaine hydrochloride
Outcomes
Primary Outcomes
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Time Frame: upto 72 hours post surgery
Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
Secondary Outcomes
- Total Narcotic Consumption in Morphine Equivalents (in Milligrams)(12,24,48 hours post surgery)
- Static Pain as Measured by the Numerical Pain Score (NPS)(6, 12, 24, 48 and 72 hours post surgery)
- Severity of Pruritus as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Severity of Nausea as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Severity of Vomiting as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Severity of Sedation as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Patient Satisfaction as Assessed by Likert Scale(72 hours post surgery)
- Dynamic Pain as Measured by the Numerical Pain Score (NPS)(6, 12, 24, 48 and 72 hours post surgery)
- Time to First Analgesic Request(72 hours post surgery)
Study Sites (2)
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