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Completed

NCT Number: NCT01022528

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone (0.1 mg/kg)

Drug

Other names: Dose = 0.1 mg/kg

Dexamethasone (0.2 mg/kg)

Drug

Other names: Dose = 0.2 mg/kg

Saline

Other

Primary outcomes

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

Secondary outcomes

  1. Total cumulative postoperative morphine consumption after 48 hours

  2. Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery

  3. Total fentanyl administration intraoperatively and in the PACU

  4. Time to first analgesic request in the PACU

  5. Time to discharge from the PACU

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2009
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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