Postoperative PainNCT01022528
Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
A study testing Dexamethasone (0.1 mg/kg), Dexamethasone (0.2 mg/kg) and Saline in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Women's College Hospital at 1 site in Canada.
Trial summary
The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Fatigue
- What is being tested?
- Dexamethasone (0.1 mg/kg), Dexamethasone (0.2 mg/kg) and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Dec 2012
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be non-lactating
- 18-65 years of age
- ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used
Who cannot join
- Emergent procedures
- Diagnosed malignancy
- History of allergy to dexamethasone
- Allergy or contraindication to drugs used in study and anesthesia
- Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
- Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs)
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- Patients who have been on long term oral steroid therapy
- Patients with BMI>40
- Serious organ disease/ dysfunction
- Chronic pain patients requiring >30mg morphine per day or equivalent
- Severe psychiatric disease
- Drug Addiction
- Pregnancy
- Language barrier
- Inability to cooperate with the use of the intravenous PCA morphine pump
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia.
This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects.
Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.
- Being tested
- Dexamethasone (0.1 mg/kg), Dexamethasone (0.2 mg/kg), Saline
- Keywords
- Elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair) or myomectomy, through a lower transverse or low midline incision under general anesthesia
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (0.1 mg/kg)Drug
Also called Dose = 0.1 mg/kg
Dexamethasone (0.2 mg/kg)Drug
Also called Dose = 0.2 mg/kg
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone (0.1 mg/kg); Drug: Dexamethasone (0.2 mg/kg) |
| Saline | Placebo comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
Secondary outcomes (5)
Total cumulative postoperative morphine consumption after 48 hours
Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
Total fentanyl administration intraoperatively and in the PACU
Time to first analgesic request in the PACU
Time to discharge from the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022528
- Sponsor's protocol ID
- 2009-0005-B
- Status last verified
- Oct 2013
- First submitted
- 27 Nov 2009
- Last updated
- 17 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
- ClinicalTrials.gov ID
- NCT01022528
- Acronym / sponsor ID
- 2009-0005-B
- Keywords
- Elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair) or myomectomy, through a lower transverse or low midline incision under general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Dec 2009 (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.
The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia.
This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects.
Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone (0.1 mg/kg), Drug: Dexamethasone (0.2 mg/kg) |
| Saline | Placebo comparator | Other: Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be non-lactating
- 18-65 years of age
- ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used
Key exclusion criteria (15 listed)
- Emergent procedures
- Diagnosed malignancy
- History of allergy to dexamethasone
- Allergy or contraindication to drugs used in study and anesthesia
- Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
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 |
|---|---|---|
| Dexamethasone (0.1 mg/kg)Also: Dose = 0.1 mg/kg | Drug | Dexamethasone |
| Dexamethasone (0.2 mg/kg)Also: Dose = 0.2 mg/kg | Drug | Dexamethasone |
| Saline | Other | Saline |
Primary outcome
Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
5 secondary outcomes
Total cumulative postoperative morphine consumption after 48 hours
Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
Total fentanyl administration intraoperatively and in the PACU
Time to first analgesic request in the PACU
Time to discharge from the PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
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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 Dexamethasone (0.1 mg/kg), Dexamethasone (0.2 mg/kg) and Saline in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Women's College Hospital at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 17 Oct 2013. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours. 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 17 Oct 2013.