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Dexamethasone for Post Cesarean Delivery Analgesia

Information source: University of Iowa
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Dexamethasone (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Iowa

Official(s) and/or principal investigator(s):
Unyime Ituk, MD, Principal Investigator, Affiliation: University of Iowa

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Postoperative analgesia

Secondary outcome: Quality of Recovery

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Locations and Contacts

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
Additional Information

Related publications:

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. Epub 2007 Sep 27. Retraction in: Int J Gynaecol Obstet. 2013 Apr;121(1):97.

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.

Starting date: March 2013
Last updated: May 26, 2015

Page last updated: August 20, 2015

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