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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Postoperative Pain; Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: Saline; Drug: Dexamethasone (0.1 mg/kg); Drug: Dexamethasone (0.2 mg/kg)

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Other: Saline
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Women's College Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 27, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): October 17, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: 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
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 2009-0005-B