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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: Saline
  • Saline infusion adjunct to morphine PCA pump
• Drug: Butorphanol tartrate
  • Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
• Drug: Tramadol Hydrochloride
  • 100mg tramadol was used preemptively to morphine PCA pump
• Drug: Saline
  • Preemptive saline as a control group to tramadol one

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Butorphanol basal infusion adjunct to morphine PCA
• Experimental: 2
  • Saline infusion adjunct to morphine PCA
• Experimental: 3
  • Premedication of Tramadol
• Experimental: 4
  • Preemptive saline for morphine PCA

Primary Measures

• VAS pain scoring;
  • Time Frame: 5 months
    Safety Issue?: Yes

Secondary Measures

• VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.
  • Time Frame: 5 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nanjing Medical University

Overall Clinical Trial Officials and Contacts

XiaoFeng Shen, MD Study Chair Nanjing Medical University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00510666

Study ID Number: NMU-2579-3FW

ClinicalTrials.gov Identifier: NCT00510666

Health Authority: China: Nanjing Bureau of Health