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NCT Number: NCT01868633

Dexamethasone 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

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English Speaking
  • Non-laboring women
  • Scheduled Elective Cesarean section under spinal anesthesia
  • American Society of Anesthesiologists I-II physical status

Exclusion criteria

  • Contraindications to spinal anesthesia
  • allergy to study medication
  • patients with allergy to morphine
  • patients with uncontrolled hypertension
  • history of peptic ulcer disease
  • liver cirrhosis
  • 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.

Treatment and study plan

Dexamethasone

Drug

Other names: Decadron

Placebo

Drug

Other names: Normal saline

Primary outcomes

  1. Postoperative Analgesia

    Time frame: 24 hours

    Comparison of postoperative opioid analgesia use between the 2 groups

Secondary outcomes

  1. Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery

    Time frame: 24 hours

    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

  2. Quality of Recovery

    Time frame: 48 hours

    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

  3. Incidence and Severity of Nausea and Pruritus

    Time frame: 24 hours

    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)

Other outcomes

  1. Number of Participants With Chronic Pain After Cesarean Delivery

    Time frame: 6 months

    Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2013
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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