NCT01492075

Brief Summary

The investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

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, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

October 7, 2011

Last Update Submit

September 26, 2015

Conditions

Abdominal Hysterectomy

Keywords

Postoperative painAnesthetics: Local anestheticsSurgery: Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Total morphine consumption 0 - 24 h postoperatively

    0-24 h

Secondary Outcomes (3)

  • Postoperative pain

    0 - 48 h postoperatively

  • PONV

    0 - 48 h postoperatively

  • Home discharge

    0-10 days

Study Arms (2)

Continuous infusion

ACTIVE COMPARATOR

Continuous infusion of LA intraabdominally

Drug: PCRA (Intermittent injection)

PCRA (Intermittent injection)

EXPERIMENTAL

Patient controlled LA intraabdominally

Drug: PCRA (Intermittent injection)

Interventions

PCRA (Intermittent injection)DRUG

Intermittent injection of LA intraabdominally

Continuous infusionPCRA (Intermittent injection)

Eligibility Criteria

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

You may qualify if:

  • year old patients undergoing open abdominal hysterectomy.
  • ASA I - II (Appendix 1).
  • Have signed and dated Informed Consent.
  • Willing and able to comply with the protocol for the duration of the trial.

You may not qualify if:

  • Patients undergoing open abdominal hysterectomy due to suspected cancer.
  • Patients with chronic pain who are taking analgesics regularly.
  • Allergy to components in levobupivacaine (Chirocaine)/Saline (Sodium Chloride).
  • Participation in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Andrea Perniola, MD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

  • Anil Gupta, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 7, 2011

First Posted

December 14, 2011

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

SE(1)