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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510666
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : March 31, 2009
HRSA/Maternal and Child Health Bureau
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Hysterectomy Drug: Saline Drug: Butorphanol tartrate Drug: Tramadol Hydrochloride Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 841 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy
Study Start Date : January 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Butorphanol basal infusion adjunct to morphine PCA
Drug: Butorphanol tartrate
Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
Other Name: BT
Experimental: 2
Saline infusion adjunct to morphine PCA
Drug: Saline
Saline infusion adjunct to morphine PCA pump
Other Name: SA
Experimental: 3
Premedication of Tramadol
Drug: Tramadol Hydrochloride
100mg tramadol was used preemptively to morphine PCA pump
Other Name: TH
Experimental: 4
Preemptive saline for morphine PCA
Drug: Saline
Preemptive saline as a control group to tramadol one
Other Name: PS

Primary Outcome Measures :
  1. VAS pain scoring; [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions. [ Time Frame: 5 months ]

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510666

China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Study Chair: XiaoFeng Shen, MD Nanjing Medical University

Publications of Results:
Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital Identifier: NCT00510666     History of Changes
Other Study ID Numbers: NMU-2579-3FW
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by Nanjing Medical University:
Pain, Postoperative
Analgesics, Opioid
Analgesia, Patient-Controlled
Pain Measurement

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Narcotic Antagonists