Dexamethasone for Post Cesarean Delivery Analgesia

Phase 4

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Placebo injection and spinal morphine	Placebo	intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Dexamethasone & spinal morphine	Dexamethasone	intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Primary Outcome Measures

Name	Time	Method
Postoperative Analgesia	24 hours	Comparison of postoperative opioid analgesia use between the 2 groups

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery	24 hours	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
Quality of Recovery	48 hours	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
Incidence and Severity of Nausea and Pruritus	24 hours	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)