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

Primary Purpose

Postoperative Pain, Hysterectomy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Saline
Butorphanol tartrate
Tramadol Hydrochloride
Saline
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Postoperative, Analgesics, Opioid, Analgesia, Patient-Controlled, Pain Measurement

Eligibility Criteria

19 Years - 64 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Nanjing Maternal and Child Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Butorphanol basal infusion adjunct to morphine PCA

Saline infusion adjunct to morphine PCA

Premedication of Tramadol

Preemptive saline for morphine PCA

Outcomes

Primary Outcome Measures

VAS pain scoring;

Secondary Outcome Measures

VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.

Full Information

First Posted
August 1, 2007
Last Updated
March 30, 2009
Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT00510666
Brief Title
Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy
Acronym
BATPCAH
Official Title
Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hysterectomy
Keywords
Pain, Postoperative, Analgesics, Opioid, Analgesia, Patient-Controlled, Pain Measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
841 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Butorphanol basal infusion adjunct to morphine PCA
Arm Title
2
Arm Type
Experimental
Arm Description
Saline infusion adjunct to morphine PCA
Arm Title
3
Arm Type
Experimental
Arm Description
Premedication of Tramadol
Arm Title
4
Arm Type
Experimental
Arm Description
Preemptive saline for morphine PCA
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
SA
Intervention Description
Saline infusion adjunct to morphine PCA pump
Intervention Type
Drug
Intervention Name(s)
Butorphanol tartrate
Other Intervention Name(s)
BT
Intervention Description
Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
Intervention Type
Drug
Intervention Name(s)
Tramadol Hydrochloride
Other Intervention Name(s)
TH
Intervention Description
100mg tramadol was used preemptively to morphine PCA pump
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
PS
Intervention Description
Preemptive saline as a control group to tramadol one
Primary Outcome Measure Information:
Title
VAS pain scoring;
Time Frame
5 months
Secondary Outcome Measure Information:
Title
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Maternal and Child Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19122548
Citation
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.
Results Reference
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Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy

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