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

NCT00510666 — Phase 4, Completed, 841 participants, Nanjing Medical University

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Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Registry	NCT00510666, acronym BATPCAH
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	841 (Actual)
Sponsor	Nanjing Medical University (Other); collaborators: HRSA/Maternal and Child Health Bureau
Conditions	Postoperative Pain, Hysterectomy
Interventions	Saline, Butorphanol tartrate, Tramadol Hydrochloride (Drug)
Dates	start 2007-01-01, primary completion 2007-05-01, completion 2007-05-01, first posted 2007-08-02, last updated 2009-03-31
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: Butorphanol tartrate	Butorphanol basal infusion adjunct to morphine PCA
2	Experimental	Drug: Saline	Saline infusion adjunct to morphine PCA
3	Experimental	Drug: Tramadol Hydrochloride	Premedication of Tramadol
4	Experimental	Drug: Saline	Preemptive saline for morphine PCA

Saline (Drug), also known as SA: Saline infusion adjunct to morphine PCA pump
Butorphanol tartrate (Drug), also known as BT: Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
Tramadol Hydrochloride (Drug), also known as TH: 100mg tramadol was used preemptively to morphine PCA pump
Saline (Drug), also known as PS: Preemptive saline as a control group to tramadol one

+Outcome measures

Primary outcomes

VAS pain scoring; [5 months]

Secondary outcomes

VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions. [5 months]

+Eligibility

Sex: Female, ages: 19 Years to 64 Years

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 (1)

Facility	City	Country	Status
Nanjing Maternal and Child Care Hospital	Nanjing, Jiangsu	China

+Publications

Results publication: 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. doi: 10.1097/EJA.0b013e32831a6aa2. PMID 19122548

+Investigators

XiaoFeng Shen, MD, Study chair, Nanjing Medical University