Back to resultsStudy to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
Primary Purpose
Post Operative Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.25% bupivicaine will be injected at the study port site prior to incision
Saline will be injected at the study port site prior to incision
Saline will be in injected into the port site prior to closure
0.25% bupivicaine will be injected into the port site prior to closure
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring pain, laparoscopy, reduction
Eligibility Criteria
Inclusion Criteria:
- patients undergoing laparoscopic surgery
Exclusion Criteria:
- Cardiovascular instability
- malignancies
- pulmonary conditions incompatible with laparoscopic surgery
Sites / Locations
- Stony Brook University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Preincision Placebo
Preincision Marcaine
Postincision Placebo
Postincision marcaine
Arm Description
This group of patients will receive saline injection at study port site before incision
This group will receive marcaine injection at the study port site prior to incision
This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure
This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure
Outcomes
Primary Outcome Measures
Reduction in post-operative pain at large lateral port sites
visual analog scoring of post-operative pain in a control and a treatment group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01452633
Brief Title
Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
Official Title
Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
pain, laparoscopy, reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preincision Placebo
Arm Type
Placebo Comparator
Arm Description
This group of patients will receive saline injection at study port site before incision
Arm Title
Preincision Marcaine
Arm Type
Active Comparator
Arm Description
This group will receive marcaine injection at the study port site prior to incision
Arm Title
Postincision Placebo
Arm Type
Placebo Comparator
Arm Description
This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure
Arm Title
Postincision marcaine
Arm Type
Active Comparator
Arm Description
This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure
Intervention Type
Drug
Intervention Name(s)
0.25% bupivicaine will be injected at the study port site prior to incision
Other Intervention Name(s)
marcaine
Intervention Description
Injection will precede the incision
Intervention Type
Drug
Intervention Name(s)
Saline will be injected at the study port site prior to incision
Other Intervention Name(s)
normal saline
Intervention Description
Injection will precede incision
Intervention Type
Drug
Intervention Name(s)
Saline will be in injected into the port site prior to closure
Intervention Description
Saline will be injected into the port site prior to the closure without any preincisional intervention
Intervention Type
Drug
Intervention Name(s)
0.25% bupivicaine will be injected into the port site prior to closure
Other Intervention Name(s)
marcaine
Intervention Description
0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention
Primary Outcome Measure Information:
Title
Reduction in post-operative pain at large lateral port sites
Description
visual analog scoring of post-operative pain in a control and a treatment group
Time Frame
4 and 24 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing laparoscopic surgery
Exclusion Criteria:
Cardiovascular instability
malignancies
pulmonary conditions incompatible with laparoscopic surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James N Droesch, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James N Droesch, MD
Phone
631-444-2757
Email
james.droesch@sbumed.org
First Name & Middle Initial & Last Name & Degree
Todd Griffin, MD
Phone
6314442757
Email
todd.griffin@sbumed.org
First Name & Middle Initial & Last Name & Degree
James N Droesch, MD
12. IPD Sharing Statement
Learn more about this trial
Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
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