NCT00209872

Brief Summary

The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).

Trial Health

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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
Last Updated

November 7, 2007

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

November 6, 2007

Conditions

Planned Abdominal Hysterectomy

Outcome Measures

Primary Outcomes (3)

  • Postoperative abilities over time

  • Discharge time from PACU according to fixed criteria

  • Consumption of analgesics and antiemetics in the PACU

Secondary Outcomes (3)

  • Degree of nursing requirements at the PACU

  • General tolerability of the regimes

  • Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively

Interventions

GabapentinDRUG
LidocaineDRUG
S-ketamineDRUG
Epidural analgesiaPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned abdominal hysterectomy with or without BSO
  • Age above 18 years
  • Written informed consent
  • American Society of Anesthesiologists (ASA) class I-III

You may not qualify if:

  • Planned vaginal or laparoscopic hysterectomy
  • Hysterectomy as part of other surgery
  • Allergy to part of the treatment regimen
  • Previous reactions to opioids (nausea, cognition)
  • Previous inability to place correct epidural catheter
  • Severe state anxiety according to the OCAP or STAI
  • ASA class IV
  • Dependency on alcohol, opioids or central stimulants
  • Chronic pain condition
  • Hemorrhagic diathesis
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anaesthesia, Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Related Links

MeSH Terms

Interventions

GabapentinLidocaineEsketamineAnalgesia, Epidural

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsAcetanilidesAnilidesAmidesAniline CompoundsAnalgesiaAnesthesia and Analgesia

Study Officials

  • Kenneth Jensen, M.D.

    Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Claus Lund, Dr. Med. Sci.

    Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark

    STUDY CHAIR

Central Study Contacts

Kenneth Jensen, M.D.

CONTACT

+45 36 32 62 90kenneth.jensen@hh.hosp.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

October 1, 2005

Last Updated

November 7, 2007

Record last verified: 2005-09

Locations

DK(1)