PainPhase 4NCT01844206
Two Dose Epidural Morphine for Post-cesarean Analgesia
A Phase 4 study testing Epidural Morphine and Epidural Saline in people with Pain and Morphine Adverse Reaction, run by Columbia University at 1 site in United States.
Trial summary
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Morphine Adverse Reaction
- What is being tested?
- Epidural Morphine and Epidural Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing cesarean section under epidural anesthesia.
Who cannot join
- Emergent cesarean section
- Coagulopathy
- Failed epidural anesthesia or patchy block
- General anesthesia
- Use of epidural chloroprocaine
- Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
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- Severe opioid side effects
- History of chronic opioid use
- History of chronic pain
- History of obstructive sleep apnea
- Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
- Height under 4' 10" (147 cm)
- Documented dural puncture by the epidural (Tuohy) needle
- Preeclampsia
- Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital
New York, New York, 10032
About this study
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.
Read the detailed description
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.
The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).
- Conditions
- Pain, Morphine Adverse Reaction
- Being tested
- Epidural Morphine, Epidural Saline
- Keywords
- Post-cesarean analgesia, Second dose of epidural morphine after surgery, Post-operative analgesia, Self-administered epidural morphine, Pain management after cesarean
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural MorphineDrug
Also called DepoDur
Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
Epidural SalineDrug
Also called Sodium Chloride Solution
Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Morphine | Active comparator | Group receiving 3mg epidural morphine, 24 hours after the initial dose Receives: Drug: Epidural Morphine |
| Epidural Saline | Placebo comparator | Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. Receives: Drug: Epidural Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.
Measured: Up to 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Slow recruitment of subjects
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 (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Lee, Columbia University
- Investigators
- Allison Lee, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844206
- Sponsor's protocol ID
- AAAL3857
- Status last verified
- Nov 2015
- First submitted
- 29 Apr 2013
- Last updated
- 23 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.
PubMed 8213024Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.
PubMed 10735794
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Dose Epidural Morphine for Post-cesarean Analgesia
- ClinicalTrials.gov ID
- NCT01844206
- Acronym / sponsor ID
- AAAL3857
- Conditions
- Pain, Morphine Adverse Reaction
- Keywords
- Post-cesarean analgesia, Second dose of epidural morphine after surgery, Post-operative analgesia, Self-administered epidural morphine, Pain management after cesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment of subjects
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 23 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.
Detailed description
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.
The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Morphine | Active comparator | Drug: Epidural MorphineGroup receiving 3mg epidural morphine, 24 hours after the initial dose |
| Epidural Saline | Placebo comparator | Drug: Epidural SalineGroup receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing cesarean section under epidural anesthesia.
Key exclusion criteria (15 listed)
- Emergent cesarean section
- Coagulopathy
- Failed epidural anesthesia or patchy block
- General anesthesia
- Use of epidural chloroprocaine
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 |
|---|---|---|
| Epidural MorphineAlso: DepoDurPatients will be given 3mg epidural morphine, 24 hours after the initial dose. | Drug | Epidural Morphine |
| Epidural SalineAlso: Sodium Chloride SolutionPatients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg. | Drug | Epidural Saline |
Primary outcome
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
Time frame: Up to 48 hours post-operatively
The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8213024Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.
- Background: PubMed 10735794Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.
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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.
Allison Lee, MD principal investigator
Columbia University
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 Epidural Morphine and Epidural Saline in people with Pain and Morphine Adverse Reaction, run by Columbia University 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 1 inclusion and 15 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 23 Dec 2015. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2015). 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?
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery (time frame: Up to 48 hours post-operatively). 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 NCT01844206, which also lists 2 linked publications.
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 23 Dec 2015.