Pre-emptive Local Anaesthesia in Gynecological Laparoscopy

This study is not yet open for participant recruitment.
Verified August 2012 by Helse Stavanger HF
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01677143
First received: August 24, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: Bupivacaine 5mg/ml
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Pre-emptive Local Anaesthesia in Gynecological Laparoscopy

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Postoperative movement-evoked pain [ Time Frame: 5 hours postoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain at rest [ Time Frame: 2 and 5 hours postoperative ] [ Designated as safety issue: No ]
    Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative.

  • Rescue analgetics [ Time Frame: 5 hours postoperative ] [ Designated as safety issue: No ]
    Use of rescue analgesics postoperative.


Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bupivacaine
Injection of 5 ml bupivacaine, 5mg/ml in each port site.
Drug: Bupivacaine 5mg/ml
50 mg injection as local anestesia
Other Name: Marcain
Placebo Comparator: Saline
Injection of 5 ml saline in each port site.
Drug: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677143

Contacts
Contact: Ravndal Caroline, MD caroline.ravndal@sus.no

Locations
Norway
Stavanger University Hospital Not yet recruiting
Stavanger, Norway, 4068
Contact: Caroline Ravndal, MD       caroline.ravndal@sus.no   
Principal Investigator: Caroline Ravndal, MD         
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Caroline Ravndal, MD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01677143     History of Changes
Other Study ID Numbers: SUS2012CMR01, 2012-002356-16
Study First Received: August 24, 2012
Last Updated: August 30, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:
Local anesthetic
Preemptive analgesia
Postoperative pain
Laparoscopy
Gynecological surgery
Day-case surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014