Comparison of Butorphanol and Tramadol Associated PCA After Hysterectomy
Information source: Nanjing Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Saline (Drug); Butorphanol tartrate (Drug); Tramadol Hydrochloride (Drug); Saline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Nanjing Medical University Official(s) and/or principal investigator(s):
XiaoFeng Shen, MD, Study Chair, Affiliation: Nanjing Medical University
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. We hypothesized that butorphanol and tramadol can produce different
analgesic effects with intravenous PCA after abdominal hysterectomy.
Clinical Details
Official title: Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: VAS pain scoring;
Secondary outcome: VAS sedation scoring;
VAS happiness scoring;
Adverse effects;
Patient's overall conditions.
Eligibility
Minimum age: 19 Years.
Maximum age: 64 Years.
Gender(s): Female.
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.
Locations and Contacts
Nanjing Maternal and Child Care Hospital, Nanjing, Jiangsu 210004, China
Additional Information
Starting date: January 2007
Ending date: May 2007
Last updated: April 17, 2008
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