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PregnancyNCT02112422

The Role of Timing of Dexamethasone Administration on Pain Scores and Quality of Recovery in Cesarean Section.

A study testing Intervention in people with Pregnancy, run by University of Manitoba at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of our study was to evaluate the hypothesis that single dose dexamethasone given sixty minutes preoperatively reduces visual analog scale (VAS) pain scores and improves quality of recovery in patients undergoing elective cesarean section as compared to the same dose given immediately prior to skin incision. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Pregnancy
What is being tested?
Intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesCanada
Study dates
Apr 2014to Nov 2014
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • •Over 18 years of age
  • American Society of Anesthesiologists class I-III
  • Presenting for elective cesarean section.

Who cannot join

  • •Contraindication to regional anesthesia
  • Allergy to study drug
  • Uncontrolled diabetes
  • Active infection
  • Adrenal axis pathology
  • Active treatment with steroids
  • Treatment with oral or parenteral steroids within the previous 6 months

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Health Sciences Center

    Winnipeg, Manitoba, R3A1R9

  • Winnipeg Health Sciences Center

    Winnipeg, Manitoba, R3Y-0A9

Other trials in Canada

About this study

The purpose of our study was to evaluate the hypothesis that single dose dexamethasone given sixty minutes preoperatively reduces visual analog scale (VAS) pain scores and improves quality of recovery in patients undergoing elective cesarean section as compared to the same dose given immediately prior to skin incision.

Read the detailed description

Dexamethasone, a potent synthetic glucocorticoid with minimal mineralocorticoid effects, is commonly administered as an anesthesia adjunct for the prevention of postoperative nausea and vomiting (PONV). Over the last two decades the analgesic effects of dexamethasone have also been demonstrated in the treatment of acute and chronic pain. Two recent meta-analyses of over thirty randomized clinical trials (close to 5,000 subjects) concluded that dexamethasone at doses more than 0.1 mg/kg is an effective adjunct in multimodal strategies to reduce postoperative pain and opioid consumption after a variety of surgeries.

Cesarean section is a common surgical procedure and associated with a moderate amount of postoperative pain (Visual analogue score (VAS) of 3-5, on a 10 point scale). Patients' postoperative experience closely correlates with their perception of pain management. Controlling postoperative pain after cesarean section remains an important clinical challenge. A multimodal approach to reduce pain has become a standard of care and includes varying doses of intrathecal local anesthetic, intrathecal morphine, co-administration of opioids or other adjuncts such as non-steroidal anti-inflammatory drugs and acetaminophen. Dexamethasone is typically administered in the elective cesarean section population for the prevention of intrathecal opioid induced PONV. Recently however, the potential benefit of single dose dexamethasone has been demonstrated in improving postoperative analgesia in this patient population.

The analgesic effect of dexamethasone in post-cesarean section parturients is likely to be mediated via its anti-inflammatory actions. This does not come as a surprise given the profound inflammatory changes associated with the peripartum period and cesarean sections. Until the late third trimester. pregnancy is thought to be associated with suppression of a variety of humoral and cell-mediated immunological functions to accommodate the "foreign" semi-allogeneic fetal graft. The proinflammatory milleu becomes up regulated in late pregnancy and around the time of delivery. Specifically, during the third trimester, the percentage of granulocytes and cluster of differentiation 8 (CD8+) T lymphocytes are significantly increased, along with a concomitant reduction in the percentages of cluster of differentiation 4 (CD4+) T lymphocytes and monocytes. During the peripartum and delivery period, leukocyte count may become markedly elevated, attaining levels of 25,000/μL or greater. Moreover, circulating leukocytes undergo significant phenotypic changes including the upregulation of adhesion molecules. Other markers of inflammation including C-reactive protein, erythrocyte sedimentation rate (ESR) and complement factors C3 and C4 are all increased in normal pregnancy and significantly so during labour.

Cesarean section itself causes significant surgical stress and results in a profound inflammatory response. Inflammation is triggered not only by direct tissue injury from surgical incision and deeper tissue trauma but also by "spillage" of highly pro-inflammatory mediators from amniotic fluid and placental tissue into the pelvic cavity as well as systemic circulation.

As a result of the inflammatory insults of pregnancy and cesarean section, dexamethasone has emerged as an important adjunct in postoperative pain control in this patient population. Unanswered, however, is the role that the timing of dexamethasone administration may play in its analgesic action. Dexamethasone peak effect is delayed by 60-90 minutes reflecting its unique pharmacodynamics. Unbound dexamethasone crosses cell membranes and binds with high affinity to specific cytoplasmic glucocorticoid receptors. This complex binds to DNA elements (glucocorticoid response elements) which results in a modification of transcription and protein synthesis. This leads to inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, suppression of humoral immune responses, and reduction in edema or scar tissue. Direct anti-inflammatory actions of dexamethasone are thought to involve phospholipase A2 inhibitory proteins and lipocortins (which control the biosynthesis prostaglandins and leukotrienes). This multistep mechanism of action may explain why administration of dexamethasone prior to the stress of surgery may optimize its therapeutic effects including analgesia and anti-emesis. However, the vast majority of studies on dexamethasone administer the drug immediately prior to or during surgery.

The purpose of this randomized, double-blinded trial is to determine if single dose dexamethasone given 45-60 minutes preoperatively reduces VAS pain scores and improves quality of recovery in patients undergoing elective cesarean section as compared to the same dose given immediately after surgical incision.

Conditions
Pregnancy
Being tested
Control, Intervention
Keywords
Parturients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ControlDrug

    Also called 0.15 mg/kg dexamethasone IV prior to skin incision.

    The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.

  • InterventionDrug

    Also called 0.15 mg/kg of dexamethasone IV 60 minutes prior to the OR.

    Patients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR.

Study groups in NCT02112422
Study groupRoleWhat they receive
ControlActive comparatorPatients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR. The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.
Receives: Drug: Control
InterventionExperimentalPatients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR. The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.
Receives: Drug: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain using visual analogue score.

    Measured: 24 hours

Secondary outcomes (1)
  1. Number of episodes of Nausea and Vomiting

    Measured: 24 hours post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112422
Sponsor's protocol ID
B2013:159
Status last verified
Apr 2015
First submitted
8 Apr 2014
Last updated
30 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Pregnancy, run by University of Manitoba at 2 sites 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 7 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Postoperative Pain using visual analogue score. (time frame: 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 30 Apr 2015.

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