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Dexamethasone for Post Cesarean Delivery Analgesia

NCT ID: NCT01868633

Last Updated: 2017-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone & spinal morphine

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Dexamethasone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Decadron Normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Unyime Ituk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Unyime Ituk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17900579 (View on PubMed)

Murphy 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.

Reference Type BACKGROUND
PMID: 21297442 (View on PubMed)

Other Identifiers

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201210765

Identifier Type: -

Identifier Source: org_study_id