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Pre-emptive Local Anaesthesia in Gynecological Laparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01677143
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : April 26, 2016
Information provided by (Responsible Party):
Helse Stavanger HF

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Bupivacaine 5mg/ml Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Pre-emptive Local Anaesthesia in Gynecological Laparoscopy
Study Start Date : February 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: bupivacaine
Injection of 5 ml bupivacaine, 5mg/ml in each port site.
Drug: Bupivacaine 5mg/ml
5 ml in trocar area
Other Name: Marcain

Placebo Comparator: Placebo
Injection of 5 ml saline in each port site.
Drug: Bupivacaine 5mg/ml
5 ml in trocar area
Other Name: Marcain

Primary Outcome Measures :
  1. Postoperative movement-evoked pain [ Time Frame: 5 hours postoperative ]
    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 :
  1. Pain at rest [ Time Frame: 2 and 5 hours postoperative ]
    Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative.

  2. Rescue analgetics [ Time Frame: 5 hours postoperative ]
    Use of rescue analgesics postoperative.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01677143

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Stavanger University Hospital
Stavanger, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
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Principal Investigator: Caroline Ravndal, MD Helse Stavanger HF

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Responsible Party: Helse Stavanger HF Identifier: NCT01677143     History of Changes
Other Study ID Numbers: SUS2012CMR01
2012-002356-16 ( EudraCT Number )
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Keywords provided by Helse Stavanger HF:
Local anesthetic
Preemptive analgesia
Postoperative pain
Gynecological surgery
Day-case surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents