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

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022528
• Other study ID #: 2009-0005-B
• Status: Completed
• Phase: N/A
• First received: November 27, 2009
• Last updated: October 15, 2013
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Drug:
• Dexamethasone (0.1 mg/kg)

• Dexamethasone (0.2 mg/kg)

Other:
• Saline

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
Secondary	Total cumulative postoperative morphine consumption after 48 hours
Secondary	Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
Secondary	Total fentanyl administration intraoperatively and in the PACU
Secondary	Time to first analgesic request in the PACU
Secondary	Time to discharge from the PACU