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

NCT ID: NCT00510666

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

841 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Hysterectomy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Butorphanol basal infusion adjunct to morphine PCA

Group Type EXPERIMENTAL

Butorphanol tartrate

Intervention Type DRUG

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

2

Saline infusion adjunct to morphine PCA

Group Type EXPERIMENTAL

Saline

Intervention Type DRUG

Saline infusion adjunct to morphine PCA pump

3

Premedication of Tramadol

Group Type EXPERIMENTAL

Tramadol Hydrochloride

Intervention Type DRUG

100mg tramadol was used preemptively to morphine PCA pump

4

Preemptive saline for morphine PCA

Group Type EXPERIMENTAL

Saline

Intervention Type DRUG

Preemptive saline as a control group to tramadol one

Interventions

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Saline

Saline infusion adjunct to morphine PCA pump

Intervention Type DRUG

Butorphanol tartrate

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

Intervention Type DRUG

Tramadol Hydrochloride

100mg tramadol was used preemptively to morphine PCA pump

Intervention Type DRUG

Saline

Preemptive saline as a control group to tramadol one

Intervention Type DRUG

Other Intervention Names

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SA BT TH PS

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Maternal and Child Health Hospital

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_CHAIR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 19122548 (View on PubMed)

Other Identifiers

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NMU2007092

Identifier Type: -

Identifier Source: secondary_id

NMU-2579-3FW

Identifier Type: -

Identifier Source: org_study_id