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

Postoperative Pain Clinical Trial

— BATPCAH  

Official title:

Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510666
• Other study ID #: NMU-2579-3FW
• Secondary ID: NMU2007092
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2007
• Last updated: March 30, 2009
• Start date: January 2007
• Est. completion date: May 2007

Study information

• Verified date: March 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Nanjing Bureau of HealthChina: Nanjing Medical University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 841
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Saline
Saline infusion adjunct to morphine PCA pump
• Butorphanol tartrate
Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
• Tramadol Hydrochloride
100mg tramadol was used preemptively to morphine PCA pump
• Saline
Preemptive saline as a control group to tramadol one

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

References & Publications (1)

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):28-3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain scoring;		5 months	Yes
Secondary	VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.		5 months	Yes