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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
  Purpose

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 Intervention Phase
Postoperative Pain
Hysterectomy
 Drug: Saline
Drug: Butorphanol tartrate
Drug: Tramadol Hydrochloride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • VAS pain scoring; [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment: 841
Study Start Date: January 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510666

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

Publications:

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
ClinicalTrials.gov Identifier: NCT00510666     History of Changes
Other Study ID Numbers: NMU-2579-3FW, NMU2007092
Study First Received: August 1, 2007
Last Updated: March 30, 2009
Health Authority: China: Nanjing Bureau of Health
China: Nanjing Medical University

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Butorphanol
Morphine
Tramadol
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 21, 2013