Back to resultsA 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
Primary Purpose
Pain, Postoperative
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intrathecal morphine sulfate (ITM)
Bupivacaine hydrochloride
ropivacaine hydrochloride
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring post c section pain, pain control after baby, nerve block for post delivery pain
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
- 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)
Sites / Locations
- Memorial Hermann Hospital TMC
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Group 1 (Control group)
Group 2(Bupivacaine hydrochloride group)
Group 3 (ropivacaine hydrochloride group)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated.
Static Pain as Measured by the Numerical Pain Score (NPS)
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).
Severity of Pruritus as Assessed by a Scale
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.
Severity of Nausea as Assessed by a Scale
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.
Severity of Vomiting as Assessed by a Scale
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.
Severity of Sedation as Assessed by a Scale
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.
Patient Satisfaction as Assessed by Likert Scale
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).
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
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).
Patient Satisfaction as Assessed by Likert Scale
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).
Patient Satisfaction as Assessed by Likert Scale
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).
Time to First Analgesic Request
Full Information
NCT ID
NCT04368364
First Posted
April 24, 2020
Last Updated
May 12, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04368364
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped early due to a conflicting study in the same patient population at the study location.
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
June 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
post c section pain, pain control after baby, nerve block for post delivery pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Control group)
Arm Type
Active Comparator
Arm Title
Group 2(Bupivacaine hydrochloride group)
Arm Type
Experimental
Arm Title
Group 3 (ropivacaine hydrochloride group)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intrathecal morphine sulfate (ITM)
Intervention Description
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrochloride
Intervention Description
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
Intervention Type
Drug
Intervention Name(s)
ropivacaine hydrochloride
Intervention Description
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Primary Outcome Measure Information:
Title
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Description
Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
Time Frame
upto 72 hours post surgery
Secondary Outcome Measure Information:
Title
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Description
Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated.
Time Frame
12,24,48 hours post surgery
Title
Static Pain as Measured by the Numerical Pain Score (NPS)
Description
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).
Time Frame
6, 12, 24, 48 and 72 hours post surgery
Title
Severity of Pruritus as Assessed by a Scale
Description
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.
Time Frame
24, 48 and 72 hours post surgery
Title
Severity of Nausea as Assessed by a Scale
Description
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.
Time Frame
24, 48 and 72 hours post surgery
Title
Severity of Vomiting as Assessed by a Scale
Description
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.
Time Frame
24, 48 and 72 hours post surgery
Title
Severity of Sedation as Assessed by a Scale
Description
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.
Time Frame
24, 48 and 72 hours post surgery
Title
Patient Satisfaction as Assessed by Likert Scale
Description
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).
Time Frame
24 hours post surgery
Title
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
Description
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).
Time Frame
6, 12, 24, 48 and 72 hours post surgery
Title
Patient Satisfaction as Assessed by Likert Scale
Description
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).
Time Frame
48 hours post surgery
Title
Patient Satisfaction as Assessed by Likert Scale
Description
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).
Time Frame
72 hours post surgery
Title
Time to First Analgesic Request
Time Frame
72 hours post surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudipta Sen, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital TMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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