Physiological Effect of DrugsPhase 4NCT04369950
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
A Phase 4 study testing 2% lidocaine with 1:200,000 epinephrine and epidural morphine and 3% 2-chloroprocaine and epidural morphine in people with Physiological Effect of Drugs and Morphine, 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 show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Physiological Effect of Drugs, Morphine, Analgesics
- What is being tested?
- 2% lidocaine with 1:200,000 epinephrine and epidural morphine and 3% 2-chloroprocaine and epidural morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to 11 Jul 2021
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant patients
- live singleton pregnancy
Who cannot join
- BMI >40
- obstructive sleep apnea
- drug abuse
- chronic pain
- chronic opioid use
- nonfunctioning epidural
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 show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h
- Conditions
- Physiological Effect of Drugs, Morphine, Analgesics, Analgesics, Opioid, Central Nervous System Depressants, Narcotics
- Being tested
- 2% lidocaine with 1:200,000 epinephrine and epidural morphine, 3% 2-chloroprocaine and epidural morphine
- Keywords
- cesarean delivery, c-section, chloroprocaine, lidocaine, 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.
2% lidocaine with 1:200,000 epinephrine and epidural morphineDrug
Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
3% 2-chloroprocaine and epidural morphineDrug
Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
| Study group | Role | What they receive |
|---|---|---|
| 2 percent Lidocaine with epinephrine and epidural morphine | Active comparator | Not described Receives: Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine |
| 3 percent 2-Chloroprocaine and epidural morphine | Experimental | Not described Receives: Drug: 3% 2-chloroprocaine and epidural morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Opioid Used
Measured: 24 hours after epidural morphine administration
Secondary outcomes (7)
Total Amount of Opioid Used
Measured: 12 hours after epidural morphine administration
Total Amount of Opioid Used
Measured: 8 hours after epidural morphine administration
Total Amount of Opioid Used
Measured: 4 hours after epidural morphine administration
Pain as Measured by a 11 Point Verbal Scale
scale ranges form 0-10, higher number indicating more pain
Measured: 4,8, 12 and 24 hours after epidural morphine administration
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
scale ranges from non,mild and moderate-severe
Measured: 4,8, 12 and 24 hours after epidural morphine administration
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
scale ranges from non,mild and moderate-severe
Measured: 4,8, 12 and 24 hours after epidural morphine administration
Time Until First Opioid Request
Measured: Up to 48 hours after epidural morphine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start11 May 2020
- Primary completion11 May 2021
- Study completion11 Jul 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological Effect of DrugsStudies 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
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linden Lee, 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
- NCT04369950
- Sponsor's protocol ID
- HSC-MS-19-0951
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2020
- Last updated
- 26 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee LO, Ramirez-Chapman AL, White DL, Zhang X, Lu M, Suresh MS. Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial. Anesth Analg. 2023 Jan 1;136(1):86-93. doi: 10.1213/ANE.0000000000006109. Epub 2022 Jun 3.
PubMed 36534717
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
- ClinicalTrials.gov ID
- NCT04369950
- Acronym / sponsor ID
- HSC-MS-19-0951
- Conditions
- Physiological Effect of Drugs, Morphine, Analgesics, Analgesics, Opioid, Central Nervous System Depressants, Narcotics
- Keywords
- cesarean delivery, c-section, chloroprocaine, lidocaine, morphine, post-operative pain, post-cesarean analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Posted 26 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 show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 percent Lidocaine with epinephrine and epidural morphine | Active comparator | Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine |
| 3 percent 2-Chloroprocaine and epidural morphine | Experimental | Drug: 3% 2-chloroprocaine and epidural morphine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant patients
- live singleton pregnancy
Key exclusion criteria (6 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 |
|---|---|---|
| 2% lidocaine with 1:200,000 epinephrine and epidural morphineEpidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written. | Drug | 2 percent Lidocaine with epinephrine and epidural morphine |
| 3% 2-chloroprocaine and epidural morphineEpidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written. | Drug | 3 percent 2-Chloroprocaine and epidural morphine |
Primary outcome
Total Amount of Opioid Used
Time frame: 24 hours after epidural morphine administration
7 secondary outcomes
Total Amount of Opioid Used
Time frame: 12 hours after epidural morphine administration
Total Amount of Opioid Used
Time frame: 8 hours after epidural morphine administration
Total Amount of Opioid Used
Time frame: 4 hours after epidural morphine administration
Pain as Measured by a 11 Point Verbal Scale
Time frame: 4,8, 12 and 24 hours after epidural morphine administration
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
Time frame: 4,8, 12 and 24 hours after epidural morphine administration
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
Time frame: 4,8, 12 and 24 hours after epidural morphine administration
Time Until First Opioid Request
Time frame: Up to 48 hours after epidural morphine administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36534717Lee LO, Ramirez-Chapman AL, White DL, Zhang X, Lu M, Suresh MS. Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial. Anesth Analg. 2023 Jan 1;136(1):86-93. doi: 10.1213/ANE.0000000000006109. Epub 2022 Jun 3.
- 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 2% lidocaine with 1:200,000 epinephrine and epidural morphine and 3% 2-chloroprocaine and epidural morphine in people with Physiological Effect of Drugs and Morphine, 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 6 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: finished, as of the sponsor's last update on 26 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 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. 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 26 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 Amount of Opioid Used (time frame: 24 hours after epidural morphine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369950, which also lists 1 linked publication.
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 26 May 2022.