Pain, PostoperativePhase 4NCT04368364
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 Phase 4 study testing Intrathecal morphine sulfate (ITM), Bupivacaine hydrochloride and ropivacaine hydrochloride in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intrathecal morphine sulfate (ITM), Bupivacaine hydrochloride and ropivacaine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2020to 29 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic pain
- Opioid tolerant patients
- Allergy to drugs used in the study.
- Cognitive dysfunction
- BMI > 40
- Coagulation disorder
Show all 12Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Hermann Hospital TMC
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
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
- Conditions
- Pain, Postoperative
- Being tested
- Intrathecal morphine sulfate (ITM), Bupivacaine hydrochloride, ropivacaine hydrochloride
- Keywords
- post c section pain, pain control after baby, nerve block for post delivery pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine sulfate (ITM)Drug
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
Bupivacaine hydrochlorideDrug
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
ropivacaine hydrochlorideDrug
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) | Active comparator | Not described Receives: Drug: Intrathecal morphine sulfate (ITM) |
| Group 2(Bupivacaine hydrochloride group) | Experimental | Not described Receives: Drug: Bupivacaine hydrochloride |
| Group 3 (ropivacaine hydrochloride group) | Experimental | Not described Receives: Drug: ropivacaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: upto 72 hours post surgery
Secondary outcomes (11)
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.
Measured: 12,24,48 hours post surgery
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).
Measured: 6, 12, 24, 48 and 72 hours post surgery
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.
Measured: 24, 48 and 72 hours post surgery
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.
Measured: 24, 48 and 72 hours post surgery
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.
Measured: 24, 48 and 72 hours post surgery
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.
Measured: 24, 48 and 72 hours post surgery
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).
Measured: 24 hours post surgery
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).
Measured: 6, 12, 24, 48 and 72 hours post surgery
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).
Measured: 48 hours post surgery
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).
Measured: 72 hours post surgery
Time to First Analgesic Request
Measured: 72 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start22 May 2020
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Why it stopped: Study was stopped early due to a conflicting study in the same patient population at the study location.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudipta Sen, The University of Texas Health Science Center, Houston
- Investigators
- Sudipta Sen, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368364
- Sponsor's protocol ID
- HSC-MS-20-0143
- Status last verified
- May 2022
- First submitted
- 24 Apr 2020
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04368364
- Acronym / sponsor ID
- HSC-MS-20-0143
- Conditions
- Pain, Postoperative
- Keywords
- post c section pain, pain control after baby, nerve block for post delivery pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped early due to a conflicting study in the same patient population at the study location.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Posted 16 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group) | Active comparator | Drug: Intrathecal morphine sulfate (ITM) |
| Group 2(Bupivacaine hydrochloride group) | Experimental | Drug: Bupivacaine hydrochloride |
| Group 3 (ropivacaine hydrochloride group) | Experimental | Drug: ropivacaine hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Chronic pain
- Opioid tolerant patients
- Allergy to drugs used in the study.
- Cognitive dysfunction
- BMI > 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphine sulfate (ITM)Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion | Drug | Group 1 (Control group) |
| Bupivacaine hydrochlorideSpinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion | Drug | Group 2(Bupivacaine hydrochloride group) |
| ropivacaine hydrochlorideSpinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride | Drug | Group 3 (ropivacaine hydrochloride group) |
Primary outcome
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.
11 secondary outcomes
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Time frame: 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
Severity of Pruritus as Assessed by a Scale
Time frame: 24, 48 and 72 hours post surgery
Severity of Nausea as Assessed by a Scale
Time frame: 24, 48 and 72 hours post surgery
Severity of Vomiting as Assessed by a Scale
Time frame: 24, 48 and 72 hours post surgery
Severity of Sedation as Assessed by a Scale
Time frame: 24, 48 and 72 hours post surgery
Patient Satisfaction as Assessed by Likert Scale
Time frame: 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
Patient Satisfaction as Assessed by Likert Scale
Time frame: 48 hours post surgery
Patient Satisfaction as Assessed by Likert Scale
Time frame: 72 hours post surgery
Time to First Analgesic Request
Time frame: 72 hours post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudipta Sen, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal morphine sulfate (ITM), Bupivacaine hydrochloride and ropivacaine hydrochloride in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Narcotic Consumption in Morphine Equivalents (in Milligrams) (time frame: upto 72 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.