Postoperative PainPhase 4NCT01868633
Dexamethasone for Post Cesarean Delivery Analgesia
A Phase 4 study testing Dexamethasone in people with Postoperative Pain, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain. We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2015
- 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
- English Speaking
- Non-laboring women
- Scheduled Elective Cesarean section under spinal anesthesia
- American Society of Anesthesiologists I-II physical status
Who cannot join
- Contraindications to spinal anesthesia
- allergy to study medication
- patients with allergy to morphine
- patients with uncontrolled hypertension
- history of peptic ulcer disease
- liver cirrhosis
Show all 14Show fewer
- diabetes mellitus
- glaucoma
- known IV drug abusers
- patients with chronic pain or on long term opioids
- patients administered steroids in the past week
- women with fetuses having known congenital abnormalities
- psychiatric illness such that they are unable to comprehend or participate in study questions
- patients on antiviral medications or live virus vaccines would also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.
We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain
Read the detailed description
After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Placebo
- Keywords
- Cesarean delivery, Analgesia, Pain, Dexamethasone, intrathecal morphine, spinal anesthesia
- Medical subject headings
- Pain, Postoperative, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
PlaceboDrug
Also called Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone & spinal morphine | Active comparator | intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively Receives: Drug: Dexamethasone |
| Placebo injection and spinal morphine | Placebo comparator | intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Analgesia
Comparison of postoperative opioid analgesia use between the 2 groups
Measured: 24 hours
Secondary outcomes (3)
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with "no pain" = 0 and "the worst possible pain = 10). Pain was assessed at rest and with movement
Measured: 24 hours
Quality of Recovery
Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group
Measured: 48 hours
Incidence and Severity of Nausea and Pruritus
Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2015
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 Postoperative PainStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Unyime Ituk, University of Iowa
- Investigators
- Unyime Ituk, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868633
- Sponsor's protocol ID
- 201210765
- Status last verified
- Aug 2017
- First submitted
- 30 May 2013
- Last updated
- 19 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fujii Y, Nakayama M. Dexamethasone for reduction of nausea, vomiting and analgesic use after gynecological laparoscopic surgery. Int J Gynaecol Obstet. 2008 Jan;100(1):27-30. doi: 10.1016/j.ijgo.2007.07.017. Epub 2007 Sep 27.
PubMed 17900579Murphy GS, Szokol JW, Greenberg SB, Avram MJ, Vender JS, Nisman M, Vaughn J. Preoperative dexamethasone enhances quality of recovery after laparoscopic cholecystectomy: effect on in-hospital and postdischarge recovery outcomes. Anesthesiology. 2011 Apr;114(4):882-90. doi: 10.1097/ALN.0b013e3181ec642e.
PubMed 21297442
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia
- ClinicalTrials.gov ID
- NCT01868633
- Acronym / sponsor ID
- 201210765
- Conditions
- Postoperative Pain
- Keywords
- Cesarean delivery, Analgesia, Pain, Dexamethasone, intrathecal morphine, spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 2 Jun 2017
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 the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.
We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain
Detailed description
After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone & spinal morphine | Active comparator | Drug: Dexamethasoneintrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively |
| Placebo injection and spinal morphine | Placebo comparator | Drug: Placebointrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English Speaking
- Non-laboring women
- Scheduled Elective Cesarean section under spinal anesthesia
- American Society of Anesthesiologists I-II physical status
Key exclusion criteria (14 listed)
- Contraindications to spinal anesthesia
- allergy to study medication
- patients with allergy to morphine
- patients with uncontrolled hypertension
- history of peptic ulcer disease
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 |
|---|---|---|
| DexamethasoneAlso: Decadron | Drug | Dexamethasone & spinal morphine |
| PlaceboAlso: Normal saline | Drug | Placebo injection and spinal morphine |
Primary outcome
Postoperative Analgesia
Time frame: 24 hours
Comparison of postoperative opioid analgesia use between the 2 groups
3 secondary outcomes
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Time frame: 24 hours
Quality of Recovery
Time frame: 48 hours
Incidence and Severity of Nausea and Pruritus
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17900579Fujii Y, Nakayama M. Dexamethasone for reduction of nausea, vomiting and analgesic use after gynecological laparoscopic surgery. Int J Gynaecol Obstet. 2008 Jan;100(1):27-30. doi: 10.1016/j.ijgo.2007.07.017. Epub 2007 Sep 27.
- Background: PubMed 21297442Murphy GS, Szokol JW, Greenberg SB, Avram MJ, Vender JS, Nisman M, Vaughn J. Preoperative dexamethasone enhances quality of recovery after laparoscopic cholecystectomy: effect on in-hospital and postdischarge recovery outcomes. Anesthesiology. 2011 Apr;114(4):882-90. doi: 10.1097/ALN.0b013e3181ec642e.
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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.
Unyime Ituk, MD principal investigator
University of Iowa
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 Dexamethasone in people with Postoperative Pain, run by University of Iowa 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 14 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 19 Sep 2017. 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 2 Jun 2017). 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?
Postoperative Analgesia (time frame: 24 hours). 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 NCT01868633, 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 19 Sep 2017.