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

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00510666
First received: August 1, 2007
Last updated: March 30, 2009
Last verified: March 2009
History of Changes

August 1, 2007
March 30, 2009
January 2007
May 2007   (final data collection date for primary outcome measure)
VAS pain scoring; [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
VAS pain scoring; [ Time Frame: 5 months ]
Complete list of historical versions of study NCT00510666 on ClinicalTrials.gov Archive Site
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
VAS sedation scoring; VAS happiness scoring; Adverse effects. [ Time Frame: 5 months ]
Not Provided
Not Provided
 
Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Pain
  • Hysterectomy
  • Drug: Saline
    Saline infusion adjunct to morphine PCA pump
    Other Name: SA
  • Drug: Butorphanol tartrate
    Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
    Other Name: BT
  • Drug: Tramadol Hydrochloride
    100mg tramadol was used preemptively to morphine PCA pump
    Other Name: TH
  • Drug: Saline
    Preemptive saline as a control group to tramadol one
    Other Name: PS
  • Experimental: 1
    Butorphanol basal infusion adjunct to morphine PCA
    Intervention: Drug: Butorphanol tartrate
  • Experimental: 2
    Saline infusion adjunct to morphine PCA
    Intervention: Drug: Saline
  • Experimental: 3
    Premedication of Tramadol
    Intervention: Drug: Tramadol Hydrochloride
  • Experimental: 4
    Preemptive saline for morphine PCA
    Intervention: Drug: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
841
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Female
19 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00510666
NMU-2579-3FW, NMU2007092
Yes
XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP