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

Overview

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.

Full Title of Study: “Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2007

Interventions

  • 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

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • VAS pain scoring;
    • Time Frame: 5 months

Secondary Measures

  • VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient’s overall conditions.
    • Time Frame: 5 months

Participating in This Clinical Trial

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: Female

Minimum Age: 19 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanjing Medical University
  • Collaborator
    • HRSA/Maternal and Child Health Bureau
  • Provider of Information About this Clinical Study
    • XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
  • Overall Official(s)
    • XiaoFeng Shen, MD, Study Chair, Nanjing Medical University

Citations Reporting on Results

Wang F, Shen X, Liu Y, Xu S, Guo X. Continuous infusion of butorphanol combined with intravenous morphine patient-controlled analgesia after total abdominal hysterectomy: a randomized, double-blind controlled trial. Eur J Anaesthesiol. 2009 Jan;26(1):28-34. doi: 10.1097/EJA.0b013e32831a6aa2.

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