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

Sponsor:	Nanjing Medical University
Collaborator:	HRSA/Maternal and Child Health Bureau
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00510666

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 IV

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

Drug Information available for: Tramadol Tramadol hydrochloride Butorphanol Butorphanol tartrate

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:

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.

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 February 09, 2012