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

Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00510666

Acronym

BATPCAH

Enrollment

841

Registered

2007-08-02

Start date

2007-01-31

Completion date

2007-05-31

Last updated

2009-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Hysterectomy

Keywords

Pain, Postoperative, Analgesics, Opioid, Analgesia, Patient-Controlled, Pain Measurement

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.

Interventions

DRUGSaline

Saline infusion adjunct to morphine PCA pump

DRUGButorphanol tartrate

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

DRUGTramadol Hydrochloride

100mg tramadol was used preemptively to morphine PCA pump

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
VAS pain scoring;	5 months

Secondary

Measure	Time frame
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.	5 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026