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

Sponsors

Lead Sponsor: Women's College Hospital

Source Women's College Hospital
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.

Overall Status Completed
Start Date March 2009
Completion Date December 2012
Primary Completion Date December 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
Secondary Outcome
Measure Time Frame
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
Enrollment 138
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone (0.1 mg/kg)

Arm Group Label: Dexamethasone

Other Name: Dose = 0.1 mg/kg

Intervention Type: Drug

Intervention Name: Dexamethasone (0.2 mg/kg)

Arm Group Label: Dexamethasone

Other Name: Dose = 0.2 mg/kg

Intervention Type: Other

Intervention Name: Saline

Arm Group Label: Saline

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Location
Facility: Women's College Hospital
Location Countries

Canada

Verification Date

October 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dexamethasone

Type: Experimental

Label: Saline

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov