Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy

Study Overview
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Brief Summary
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Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.

Official Title
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Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Conditions
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Postoperative Pain, Hysterectomy

Intervention / Treatment
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* Drug: Saline
* Drug: Butorphanol tartrate
* Drug: Tramadol Hydrochloride
* Drug: 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. Allergy to local anesthetics. Failed to perform the epidural catheterization. Those who demonstrated significant nerve-associated side effects from the insertion of the epidural needle.

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 |
| --- | --- |
| Experimental: 1<br>Butorphanol basal infusion adjunct to morphine PCA | Drug: Butorphanol tartrate<br>* Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump<br>* Other names: BT;|
| Experimental: 2<br>Saline infusion adjunct to morphine PCA | Drug: Saline<br>* Saline infusion adjunct to morphine PCA pump<br>* Other names: SA;|
| Experimental: 3<br>Premedication of Tramadol | Drug: Tramadol Hydrochloride<br>* 100mg tramadol was used preemptively to morphine PCA pump<br>* Other names: TH;|
| Experimental: 4<br>Preemptive saline for morphine PCA | Drug: Saline<br>* Preemptive saline as a control group to tramadol one<br>* Other names: PS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain scoring; |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions. |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Postoperative, Analgesics, Opioid, Analgesia, Patient-Controlled, Pain Measurement