Dexamethasone for Post Cesarean Delivery Analgesia

University of Iowa

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01868633

201210765

Details and patient eligibility

About

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

Full 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

Enrollment: 52 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Dexamethasone & spinal morphine

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Placebo injection and spinal morphine

Placebo Comparator group

Description:

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Treatment:

Drug: Placebo