Clinical trial NCT01022528: Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
Secondary outcomes:
measure: Total cumulative postoperative morphine consumption after 48 hours
measure: Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
measure: Total fentanyl administration intraoperatively and in the PACU
measure: Time to first analgesic request in the PACU
measure: Time to discharge from the PACU
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
References: