MorphinePhase 4NCT04397458
Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
A Phase 4 study testing Saline, Bupivacaine and Dexamethasone in people with Morphine and Analgesics, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Morphine, Analgesics, Analgesics, Opioid
- What is being tested?
- Saline, Bupivacaine and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- elective or non-elective cesarean delivery on prior day
- pain scores >5/10
Who cannot join
- BMI >40
- obstructive sleep apnea
- drug abuse
- chronic pain
- chronic opioid use
- abdominal surgeries other than cesarean delivery
- contraindications to neuraxial or regional anesthesia
- received general anesthesia or did not receive neuraxial morphine for cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.
- Being tested
- Saline, Bupivacaine, Dexamethasone
- Keywords
- quadratus lumborum block, bupivacaine, cesarean delivery, c-section, intrathecal morphine, post-operative pain, post-cesarean analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
0.9% saline on each side
BupivacaineDrug
0.25% bupivacaine (50mg) on each side
DexamethasoneDrug
3mg preservative-free dexamethasone on each side
| Study group | Role | What they receive |
|---|---|---|
| Sham Control | Sham comparator | 20 milliliters (mL) 0.9% saline on each side Receives: Drug: Saline |
| Quadratus Lumborum Block | Experimental | 20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side Receives: Drug: Bupivacaine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Measured: 48 hours after intervention
Secondary outcomes (32)
Amount of opioids used
Measured: at the time of intervention (one day following cesarean delivery)
Amount of opioids used
Measured: 6 hours after intervention
Amount of opioids used
Measured: 12 hours after intervention
Amount of opioids used
Measured: 24 hours after intervention
Amount of opioids used
Measured: 48 hours after intervention
Time from quadratus lumborum block until first opioid request
Measured: from time of intervention until time of first opioid request (up to 48 hours)
Pain as measured by an 11-point verbal pain score (at rest)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (with movement)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (at rest)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 6 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 6 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 12 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 12 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 24 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 24 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 48 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Measured: 48 hours after intervention
Nausea as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: at the time of intervention (one day following cesarean delivery)
Nausea as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 6 hours after intervention
Nausea as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 12 hours after intervention
Nausea, pruritus and sedation as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 24 hours after intervention
Nausea as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 48 hours after intervention
Pruritus as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: at the time of intervention (one day following cesarean delivery)
Pruritus as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 6 hours after intervention
Pruritus as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 12 hours after intervention
Pruritus as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 24 hours after intervention
Pruritus as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 48 hours after intervention
Sedation as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: at the time of intervention (one day following cesarean delivery)
Sedation as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 6 hours after intervention
Sedation as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 12 hours after intervention
Sedation as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 24 hours after intervention
Sedation as measured by a 3-point scale
This is measured categorically as none, mild, or moderate-severe.
Measured: 48 hours after intervention
Patient satisfaction as measured by the 5-point Likert scale
The 5-point scale ranges from extremely satisfied to not satisfied.
Measured: 48 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: COVID-19 pandemic and competing study that took precedence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorphineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Suresh, The University of Texas Health Science Center, Houston
- Investigators
- Linden Lee, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397458
- Sponsor's protocol ID
- HSC-MS-20-0124
- Status last verified
- Nov 2023
- First submitted
- 4 May 2020
- Last updated
- 3 Nov 2023
- Results posted
- No
- 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 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
- ClinicalTrials.gov ID
- NCT04397458
- Acronym / sponsor ID
- HSC-MS-20-0124
- Keywords
- quadratus lumborum block, bupivacaine, cesarean delivery, c-section, intrathecal morphine, post-operative pain, post-cesarean analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic and competing study that took precedence
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
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 assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Control | Sham comparator | Drug: Saline20 milliliters (mL) 0.9% saline on each side |
| Quadratus Lumborum Block | Experimental | Drug: Bupivacaine, Drug: Dexamethasone20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elective or non-elective cesarean delivery on prior day
- pain scores >5/10
Key exclusion criteria (8 listed)
- BMI >40
- obstructive sleep apnea
- drug abuse
- chronic pain
- chronic opioid use
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 |
|---|---|---|
| Saline0.9% saline on each side | Drug | Sham Control |
| Bupivacaine0.25% bupivacaine (50mg) on each side | Drug | Quadratus Lumborum Block |
| Dexamethasone3mg preservative-free dexamethasone on each side | Drug | Quadratus Lumborum Block |
Primary outcome
Total opioid consumption
Time frame: 48 hours after intervention
32 secondary outcomes
Amount of opioids used
Time frame: at the time of intervention (one day following cesarean delivery)
Amount of opioids used
Time frame: 6 hours after intervention
Amount of opioids used
Time frame: 12 hours after intervention
Amount of opioids used
Time frame: 24 hours after intervention
Amount of opioids used
Time frame: 48 hours after intervention
Time from quadratus lumborum block until first opioid request
Time frame: from time of intervention until time of first opioid request (up to 48 hours)
Pain as measured by an 11-point verbal pain score (at rest)
Time frame: at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (with movement)
Time frame: at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (at rest)
Time frame: 6 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time frame: 6 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
Time frame: 12 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time frame: 12 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
Time frame: 24 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time frame: 24 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)
Time frame: 48 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)
Time frame: 48 hours after intervention
Nausea as measured by a 3-point scale
Time frame: at the time of intervention (one day following cesarean delivery)
Nausea as measured by a 3-point scale
Time frame: 6 hours after intervention
Nausea as measured by a 3-point scale
Time frame: 12 hours after intervention
Nausea, pruritus and sedation as measured by a 3-point scale
Time frame: 24 hours after intervention
Nausea as measured by a 3-point scale
Time frame: 48 hours after intervention
Pruritus as measured by a 3-point scale
Time frame: at the time of intervention (one day following cesarean delivery)
Pruritus as measured by a 3-point scale
Time frame: 6 hours after intervention
Pruritus as measured by a 3-point scale
Time frame: 12 hours after intervention
Pruritus as measured by a 3-point scale
Time frame: 24 hours after intervention
Pruritus as measured by a 3-point scale
Time frame: 48 hours after intervention
Sedation as measured by a 3-point scale
Time frame: at the time of intervention (one day following cesarean delivery)
Sedation as measured by a 3-point scale
Time frame: 6 hours after intervention
Sedation as measured by a 3-point scale
Time frame: 12 hours after intervention
Sedation as measured by a 3-point scale
Time frame: 24 hours after intervention
Sedation as measured by a 3-point scale
Time frame: 48 hours after intervention
Patient satisfaction as measured by the 5-point Likert scale
Time frame: 48 hours after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- 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.
Linden Lee, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline, Bupivacaine and Dexamethasone in people with Morphine and Analgesics, run by The University of Texas Health Science Center, Houston at 1 site 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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 opioid consumption (time frame: 48 hours after intervention). 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 3 Nov 2023.