NCT01677143

Brief Summary

Pre-emptive local anaesthetics are widely used in laparoscopic surgery, but there is no really consistent evidence that it is useful. Studies in the literature have shown contradicting results. At our hospital we are currently using pre-emptive local anaesthetics in the trocar areas, but as the literature does not give a clear and clinically relevant answer, we need to find out more. This study aims to see if pre-emptive local anaesthetics are useful in the setting of our day-case, laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 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

First Submitted

Initial submission to the registry

August 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

August 24, 2012

Last Update Submit

April 25, 2016

Conditions

Pain, Postoperative

Keywords

Local anestheticPreemptive analgesiaPostoperative painLaparoscopyGynecological surgeryDay-case surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative movement-evoked pain

    The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours. Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible.

    5 hours postoperative

Secondary Outcomes (2)

  • Pain at rest

    2 and 5 hours postoperative

  • Rescue analgetics

    5 hours postoperative

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

Injection of 5 ml bupivacaine, 5mg/ml in each port site.

Drug: Bupivacaine 5mg/ml

Placebo

PLACEBO COMPARATOR

Injection of 5 ml saline in each port site.

Drug: Bupivacaine 5mg/ml

Interventions

Bupivacaine 5mg/mlDRUG

5 ml in trocar area

Also known as: Marcain
Placebobupivacaine

Eligibility Criteria

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

You may qualify if:

  • Women ≥18 years of age
  • Planned day-case laparoscopic surgery
  • Signed Written Informed Consent

You may not qualify if:

  • ASA score 3-6
  • Chronic pain/ Regular use of analgesics
  • Inability to understand Norwegian language
  • Drug or alcohol abuse
  • Inability to understand or sign the Written Informed Consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, 4068, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Caroline Ravndal, MD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 24, 2012

First Posted

August 31, 2012

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 26, 2016

Record last verified: 2016-04

Locations

NO(1)