Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study

Women's College Hospital

Status: Completed

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Fatigue

Treatments: Drug: Dexamethasone (0.1 mg/kg); Other: Saline; Drug: Dexamethasone (0.2 mg/kg)

Study type: Interventional

Funder types: Other

Identifiers

NCT01022528

2009-0005-B

Details and patient eligibility

About

The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia.

This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects.

Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.

Enrollment: 138 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be non-lactating
• 18-65 years of age
• ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used

Exclusion criteria

• Emergent procedures
• Diagnosed malignancy
• History of allergy to dexamethasone
• Allergy or contraindication to drugs used in study and anesthesia
• Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
• Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs)
• Patients who have been on long term oral steroid therapy
• Patients with BMI>40
• Serious organ disease/ dysfunction
• Chronic pain patients requiring >30mg morphine per day or equivalent
• Severe psychiatric disease
• Drug Addiction
• Pregnancy
• Language barrier
• Inability to cooperate with the use of the intravenous PCA morphine pump

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Treatment:

Drug: Dexamethasone (0.2 mg/kg)

Drug: Dexamethasone (0.1 mg/kg)

Saline

Placebo Comparator group

Treatment:

Other: Saline