Skip to main content
OpenTrials
Completed

NCT Number: NCT00510666

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Agnosia Hysterectomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

19 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline

Drug

Saline infusion adjunct to morphine PCA pump

Other names: SA

Butorphanol tartrate

Drug

Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump

Other names: BT

Tramadol Hydrochloride

Drug

100mg tramadol was used preemptively to morphine PCA pump

Other names: TH

Primary outcomes

  1. VAS pain scoring;

    Time frame: 5 months

Secondary outcomes

  1. VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Acronym: BATPCAH

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 2, 2007
Registry last updated
Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.