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

NCT01022528 | Completed

• 1 other identifier: 2009-0005-B
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Fatigue

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone (0.1 mg/kg); Drug: Dexamethasone (0.2 mg/kg)

Saline

PLACEBO COMPARATOR

Other: Saline

Interventions

Dexamethasone (0.1 mg/kg) DRUG

Also known as: Dose = 0.1 mg/kg

Dexamethasone

Dexamethasone (0.2 mg/kg) DRUG

Also known as: Dose = 0.2 mg/kg

Dexamethasone

Saline OTHER

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be non-lactating
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Fatigue

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2009
• First Posted: December 1, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 17, 2013

Record last verified: 2013-10

Locations

CA (1)