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

Phase 4

Completed

• Conditions: Postoperative Pain; Hysterectomy
• Interventions: Drug: Saline; Drug: Tramadol Hydrochloride; Drug: Butorphanol tartrate

• Registration Number: NCT00510666
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 841

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Saline	Saline infusion adjunct to morphine PCA
3	Tramadol Hydrochloride	Premedication of Tramadol
4	Saline	Preemptive saline for morphine PCA
1	Butorphanol tartrate	Butorphanol basal infusion adjunct to morphine PCA

Primary Outcome Measures

Name	Time	Method
VAS pain scoring;	5 months

Secondary Outcome Measures

Name	Time	Method
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.	5 months

Trial Locations

Locations (1)

Nanjing Maternal and Child Care Hospital; 🇨🇳 Nanjing, Jiangsu, China