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Dexamethasone for Post Cesarean Delivery Analgesia

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ClinicalTrials.gov Identifier: NCT01868633
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : June 2, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Unyime Ituk, University of Iowa

Brief 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 reduce post cesarean delivery opioid consumption and pain


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia
Study Start Date : March 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Active Comparator: Dexamethasone & spinal morphine
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Drug: Dexamethasone
Other Name: Decadron

Placebo Comparator: Placebo injection and spinal morphine
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Drug: Placebo
Other Name: Normal saline




Primary Outcome Measures :
  1. Postoperative Analgesia [ Time Frame: 24 hours ]
    Comparison of postoperative opioid analgesia use between the 2 groups


Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868633


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Unyime Ituk, MD University of Iowa

Publications:
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Responsible Party: Unyime Ituk, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01868633     History of Changes
Other Study ID Numbers: 201210765
First Posted: June 4, 2013    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017

Keywords provided by Unyime Ituk, University of Iowa:
Cesarean delivery
Analgesia
Pain
Dexamethasone
intrathecal morphine
spinal anesthesia

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Morphine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents