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

Study Overview
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Brief Summary
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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
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Postoperative Pain, Postoperative Nausea and Vomiting, Fatigue

Intervention / Treatment
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* Drug: Dexamethasone (0.1 mg/kg)
* Drug: Dexamethasone (0.2 mg/kg)
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br> | Drug: Dexamethasone (0.1 mg/kg)<br> <br> * Other names: Dose = 0.1 mg/kg;Drug: Dexamethasone (0.2 mg/kg)<br> <br> * Other names: Dose = 0.2 mg/kg;|
| Placebo Comparator: Saline<br> | Other: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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