- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368364
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
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas health Science Center at Houston
-
Houston, Texas, United States, 77030
- Memorial Hermann Hospital TMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group 1 (Control group)
|
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
EXPERIMENTAL: Group 2(Bupivacaine hydrochloride group)
|
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
EXPERIMENTAL: Group 3 (ropivacaine hydrochloride group)
|
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
upto 72 hours post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Time Frame: 12,24,48 hours post surgery
|
Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated.
|
12,24,48 hours post surgery
|
Static Pain as Measured by the Numerical Pain Score (NPS)
Time Frame: 6, 12, 24, 48 and 72 hours post surgery
|
To assess static pain scores, NPS will be recorded while the participant is supine in bed.
NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).
|
6, 12, 24, 48 and 72 hours post surgery
|
Severity of Pruritus as Assessed by a Scale
Time Frame: 24, 48 and 72 hours post surgery
|
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect.
Total score ranges from 0 to 10.
|
24, 48 and 72 hours post surgery
|
Severity of Nausea as Assessed by a Scale
Time Frame: 24, 48 and 72 hours post surgery
|
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect.
Total score ranges from 0 to 10.
|
24, 48 and 72 hours post surgery
|
Severity of Vomiting as Assessed by a Scale
Time Frame: 24, 48 and 72 hours post surgery
|
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect.
Total score ranges from 0 to 10.
|
24, 48 and 72 hours post surgery
|
Severity of Sedation as Assessed by a Scale
Time Frame: 24, 48 and 72 hours post surgery
|
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect.
Total score ranges from 0 to 10.
|
24, 48 and 72 hours post surgery
|
Patient Satisfaction as Assessed by Likert Scale
Time Frame: 24 hours post surgery
|
Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1). |
24 hours post surgery
|
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
Time Frame: 6, 12, 24, 48 and 72 hours post surgery
|
To assess dynamic pain scores, the participant be asked to sit up in bed from supine to sitting, and the NPS will then be recorded.
If the participant is ambulating, the dynamic pain score during ambulation (rather during sitting) will be assessed.
NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).
|
6, 12, 24, 48 and 72 hours post surgery
|
Patient Satisfaction as Assessed by Likert Scale
Time Frame: 48 hours post surgery
|
Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1). |
48 hours post surgery
|
Patient Satisfaction as Assessed by Likert Scale
Time Frame: 72 hours post surgery
|
Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1). |
72 hours post surgery
|
Time to First Analgesic Request
Time Frame: 72 hours post surgery
|
72 hours post surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sudipta Sen, MD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Anesthetics, Local
- Bupivacaine
- Ropivacaine
- Morphine
Other Study ID Numbers
- HSC-MS-20-0143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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