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Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy

Sponsor
Stony Brook University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01452633
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
30
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.25% bupivicaine will be injected at the study port site prior to incision
  • Drug: Saline will be injected at the study port site prior to incision
  • Drug: Saline will be in injected into the port site prior to closure
  • Drug: 0.25% bupivicaine will be injected into the port site prior to closure
 N/A

Detailed Description

The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites
Study Start Date :
Nov 1, 2011
Anticipated Primary Completion Date :
May 1, 2014
Anticipated Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Preincision Placebo

This group of patients will receive saline injection at study port site before incision

Drug: Saline will be injected at the study port site prior to incision
Injection will precede incision
Other Names:
  • normal saline

    		•
    Active Comparator: Preincision Marcaine

    This group will receive marcaine injection at the study port site prior to incision

    Drug: 0.25% bupivicaine will be injected at the study port site prior to incision
    Injection will precede the incision
    Other Names:
  • marcaine

    		•
    Placebo Comparator: Postincision Placebo

    This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure

    Drug: 0.25% bupivicaine will be injected at the study port site prior to incision
    Injection will precede the incision
    Other Names:
  • marcaine

    • Drug: Saline will be in injected into the port site prior to closure
    Saline will be injected into the port site prior to the closure without any preincisional intervention
    Active Comparator: Postincision marcaine

    This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure

    Drug: 0.25% bupivicaine will be injected at the study port site prior to incision
    Injection will precede the incision
    Other Names:
  • marcaine

    • Drug: 0.25% bupivicaine will be injected into the port site prior to closure
    0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention
    Other Names:
  • marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in post-operative pain at large lateral port sites [4 and 24 hours after surgery]

      visual analog scoring of post-operative pain in a control and a treatment group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients undergoing laparoscopic surgery
    Exclusion Criteria:

    • Cardiovascular instability

    • malignancies

    • pulmonary conditions incompatible with laparoscopic surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stony Brook University Medical Center Stony Brook New York United States 11794

    Sponsors and Collaborators

    • Stony Brook University

    Investigators

    • Principal Investigator: James N Droesch, MD, Stony Brook University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Droesch, Associate Professor, Obsterics/Gynecology, Stony Brook University
    ClinicalTrials.gov Identifier:
    NCT01452633
    Other Study ID Numbers:
    • 241577-1
    First Posted:
    Oct 17, 2011
    Last Update Posted:
    Jun 10, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by James Droesch, Associate Professor, Obsterics/Gynecology, Stony Brook University
    pain
    laparoscopy
    reduction
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    No Results Posted as of Jun 10, 2013