NCT00510666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
841

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

4 months

First QC Date

August 1, 2007

Last Update Submit

March 30, 2009

Conditions

Postoperative PainHysterectomy

Keywords

Pain, PostoperativeAnalgesics, OpioidAnalgesia, Patient-ControlledPain Measurement

Outcome Measures

Primary Outcomes (1)

  • VAS pain scoring;

    5 months

Secondary Outcomes (1)

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

    5 months

Study Arms (4)

1

EXPERIMENTAL

Butorphanol basal infusion adjunct to morphine PCA

Drug: Butorphanol tartrate

2

EXPERIMENTAL

Saline infusion adjunct to morphine PCA

Drug: Saline

3

EXPERIMENTAL

Premedication of Tramadol

Drug: Tramadol Hydrochloride

4

EXPERIMENTAL

Preemptive saline for morphine PCA

Drug: Saline

Interventions

SalineDRUG

Saline infusion adjunct to morphine PCA pump

Also known as: SA
2
Butorphanol tartrateDRUG

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

Also known as: BT
1
Tramadol HydrochlorideDRUG

100mg tramadol was used preemptively to morphine PCA pump

Also known as: TH
3

Eligibility Criteria

Age19 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I-II
  • Chinese
  • Uterus myoma

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Location

Related 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):28-34. doi: 10.1097/EJA.0b013e32831a6aa2.

    PMID: 19122548RESULT

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Sodium ChlorideButorphanolTramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

CN(1)