AnalgesiaNCT00762554
Depodur vs Fentanyl Infusion for Post-C/S Analgesia
A study testing Depodur and Fentanyl in people with Analgesia, run by Goodman, Evan, M.D. at 1 site in United States.
Trial summary
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Depodur and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2009
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section
- Patient appropriate for regional anesthesia
- Patient agrees to receive regional anesthesia
- Patient willing to have an epidural infusion of medication for two days postoperatively
Who cannot join
- Morbid obesity
- History of sleep apnea
- Allergy to opioids medications
- History of opioids use during week prior to procedure
- Emergency cesarean section
- Significant surgical complications
- Contraindication or refusal to have regional anesthesia
- Age less than 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepodurDrug
Depodur 10mg given epidurally at end of cesarean section.
DepodurDrug
Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.
FentanylDrug
Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Epidural Depodur after spinal bupivacaine Receives: Drug: Depodur |
| 2 | Active comparator | Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of analgesia (measured on a 10-point scale)
Measured: 48 hours post-operatively
Secondary outcomes (1)
Frequency of minor side effects, such as pruritis or nausea.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Uncertain safety of one of the study medications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goodman, Evan, M.D.
- Responsible party
- Principal investigator, Dr. Evan Goodman, MD, Goodman, Evan, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762554
- Sponsor's protocol ID
- goodman-1
- Status last verified
- Mar 2022
- First submitted
- 29 Sep 2008
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoDur Study Group. Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study. Anesth Analg. 2005 Apr;100(4):1150-1158. doi: 10.1213/01.ANE.0000149544.58230.FF.
PubMed 15781537Carvalho B, Roland LM, Chu LF, Campitelli VA 3rd, Riley ET. Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. Anesth Analg. 2007 Jul;105(1):176-83. doi: 10.1213/01.ane.0000265533.13477.26.
PubMed 17578973
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
- ClinicalTrials.gov ID
- NCT00762554
- Acronym / sponsor ID
- goodman-1
- Conditions
- Analgesia
- Keywords
- analgesia, cesarean section, fentanyl, Depodur, Post-cesarean section analgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Uncertain safety of one of the study medications.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Goodman, Evan, M.D.
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- 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.
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DepodurEpidural Depodur after spinal bupivacaine |
| 2 | Active comparator | Drug: FentanylEpidural fentanyl infusion after epidural lidocaine or spinal bupivacaine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section
- Patient appropriate for regional anesthesia
- Patient agrees to receive regional anesthesia
- Patient willing to have an epidural infusion of medication for two days postoperatively
Key exclusion criteria (8 listed)
- Morbid obesity
- History of sleep apnea
- Allergy to opioids medications
- History of opioids use during week prior to procedure
- Emergency cesarean section
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 |
|---|---|---|
| DepodurDepodur 10mg given epidurally at end of cesarean section. | Drug | 1 |
| DepodurDepodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case. | Drug | 1 |
| FentanylEpidural fentanyl infusion started after spinal bupivacaine used for the cesarean section. | Drug | 2 |
Primary outcome
Degree of analgesia (measured on a 10-point scale)
Time frame: 48 hours post-operatively
1 secondary outcome
Frequency of minor side effects, such as pruritis or nausea.
Time frame: 48 hours postoperatively
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 29 Mar 2022.
- Background: PubMed 15781537Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoDur Study Group. Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study. Anesth Analg. 2005 Apr;100(4):1150-1158. doi: 10.1213/01.ANE.0000149544.58230.FF.
- Background: PubMed 17578973Carvalho B, Roland LM, Chu LF, Campitelli VA 3rd, Riley ET. Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. Anesth Analg. 2007 Jul;105(1):176-83. doi: 10.1213/01.ane.0000265533.13477.26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depodur and Fentanyl in people with Analgesia, run by Goodman, Evan, M.D. 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 4 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 29 Mar 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.
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?
Degree of analgesia (measured on a 10-point scale) (time frame: 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 NCT00762554, 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 29 Mar 2022.