Dexamethasone for Post Cesarean Delivery Analgesia

University of Iowa52 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain

Interventions

DexamethasoneDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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 (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Postoperative Analgesia

Comparison of postoperative opioid analgesia use between the 2 groups

Time frame: 24 hours

Secondary Outcomes

Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery

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

Time frame: 24 hours

Quality of Recovery

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

Time frame: 48 hours

Incidence and Severity of Nausea and Pruritus

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)

Time frame: 24 hours

Data from ClinicalTrials.gov

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