NCT01317368

Brief Summary

This study is conducted to evaluate different analgesic treatments effect following operation where the prostate gland is surgically removed. The different treatments the investigators wish to investigate is:

  1. 1.Transversus Abdominis Plane (TAP) block.
  2. 2.Wound infiltration
  3. 3.Placebo

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

March 11, 2011

Last Update Submit

June 19, 2012

Conditions

Postoperative Pain

Keywords

Postoperative analgesic treatmentTAP blockProstatectomyDouble blinded randomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group.

    4 hours postoperative

Secondary Outcomes (7)

  • VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)

    Recorded 0-24 hours postoperative

  • VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)

    Recorded 0-24 hours postoperative

  • Nausea

    Recorded 0-24 hours postoperative

  • Sedation

    Recorded at 0-24 hours postoperative

  • Vomiting

    Recorded 0-24 hours postoperative

  • +2 more secondary outcomes

Study Arms (3)

TAP block

ACTIVE COMPARATOR

TAP block with Ropivacaine Wound infiltration with Saline

Drug: Naropine

Wound infiltration

ACTIVE COMPARATOR

TAP block with Saline. Wound infiltration with Ropivacaine.

Drug: Naropine

Placebo

PLACEBO COMPARATOR

TAP block with Saline. Wound infiltration with Saline.

Other: Placebo

Interventions

NaropineDRUG

20 mL of 0,75% Naropin is deposited on each side (40 mL in total) in the TAP. At the same time 40 mL of saline 0,9% will be deposited subcutaneously as wound infiltration. Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.

Also known as: Ropivacaine, TAP block, Wound infiltration, Placebo
TAP block
PlaceboOTHER

20 mL 0,9% Saline is deposited on each side (40 mL in total) in the TAP. At the same time 40 mL Saline 0,9% will be given as wound infiltration. Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.

Also known as: Ropivacaine, TAP block, Wound infiltration
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 18 and \< 35
  • Patients who have given their informed consent and have fully understood the nature and limitations of the study
  • Patient who is planned for radical prostatectomy

You may not qualify if:

  • Not able to cooperate to complete the study
  • Is not able to speak and understand danish
  • Allergy towards the drugs which is used in the study
  • Daily use of strong opioids
  • Infection at the injection area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Birgitte Ruhnau, Consultant

    Department of Anaesthesiology, Abdominal Centre, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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
Consultant

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

DK(1)