Clinical trial NCT01868633: Dexamethasone for Post Cesarean Delivery Analgesia
Official title: The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Cesarean delivery
Analgesia
Pain
Dexamethasone
intrathecal morphine
spinal anesthesia
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 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.

Primary outcomes:
measure: Postoperative Analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
timeFrame: 24 hours
measure: Quality of Recovery
timeFrame: 48 hours
measure: Incidence and Severity of Nausea and Pruritus
timeFrame: 24 hours
Other outcomes:
measure: Number of Participants With Chronic Pain After Cesarean Delivery
timeFrame: 6 months
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Unyime Ituk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.