Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy

Study Overview
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Brief Summary
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Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.

Official Title
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Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy

Conditions
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Postoperative Pain, Post Operative Analgesia, Patient-Controlled Analgesia, Abdominal Surgeries

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate Injection
* Other: 0.9% Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II Chinese 19-64yr Uterus myoma Exclusion Criteria: Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records. Participants younger than 18yr，older than 65yr or pregnancy was eliminated. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study. Those who were not willing to or could not finish the whole study at any time. Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Saline with same volume added to tramadol infusion combined with morphine PCA. | Other: 0.9% Saline<br>* Saline, in same volume of 2mL<br>|
| Active Comparator: 2<br>Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA. | Drug: Dexamethasone Sodium Phosphate Injection<br>* Dexamethasone, 10mg, continuously infused up to 48h after surgeries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) of pain |  | 0-48h after surgeries | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients; |  | 0-48h after surgeries | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucocorticoid, Opioids, Balanced analgesia