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

Sponsor

Women's College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01022528

Collaborator

(none)

138

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Postoperative Nausea and Vomiting Fatigue	Drug: Dexamethasone (0.1 mg/kg) Drug: Dexamethasone (0.2 mg/kg) Other: Saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone	Drug: Dexamethasone (0.1 mg/kg) Other Names: Dose = 0.1 mg/kg Drug: Dexamethasone (0.2 mg/kg) Other Names: Dose = 0.2 mg/kg
Placebo Comparator: Saline	Other: Saline

Arm

Intervention/Treatment

Experimental: Dexamethasone

Drug: Dexamethasone (0.1 mg/kg)

Other Names:

Dose = 0.1 mg/kg

Drug: Dexamethasone (0.2 mg/kg)

Other Names:

Dose = 0.2 mg/kg

Placebo Comparator: Saline

Other: Saline

Outcome Measures

Primary Outcome Measures

Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours []

Secondary Outcome Measures

Total cumulative postoperative morphine consumption after 48 hours []
Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery []
Total fentanyl administration intraoperatively and in the PACU []
Time to first analgesic request in the PACU []
Time to discharge from the PACU []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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