Study Stopped
Study was stopped early due to a conflicting study in the same patient population at the study location.
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
1 other identifier
interventional
3
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2020
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
May 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2020
CompletedResults Posted
Study results publicly available
May 16, 2022
CompletedMay 16, 2022
May 1, 2022
1 month
April 24, 2020
March 22, 2022
May 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
upto 72 hours post surgery
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (3)
Group 1 (Control group)
ACTIVE COMPARATORGroup 2(Bupivacaine hydrochloride group)
EXPERIMENTALGroup 3 (ropivacaine hydrochloride group)
EXPERIMENTALInterventions
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Hermann Hospital TMC
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sudipta Sen, MD, Assistant Professor
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Sudipta Sen, MD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 24, 2020
First Posted
April 29, 2020
Study Start
May 22, 2020
Primary Completion
June 29, 2020
Study Completion
June 29, 2020
Last Updated
May 16, 2022
Results First Posted
May 16, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share