Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites
Overview
- Phase
- N/A
- Intervention
- Saline will be injected at the study port site prior to incision
- Conditions
- Post Operative Pain
- Sponsor
- Stony Brook University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reduction in post-operative pain at large lateral port sites
- Last Updated
- 12 years ago
Overview
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.
Investigators
James Droesch
Associate Professor, Obsterics/Gynecology
Stony Brook University
Eligibility Criteria
Inclusion Criteria
- •patients undergoing laparoscopic surgery
Exclusion Criteria
- •Cardiovascular instability
- •malignancies
- •pulmonary conditions incompatible with laparoscopic surgery
Arms & Interventions
Preincision Placebo
This group of patients will receive saline injection at study port site before incision
Intervention: Saline will be injected at the study port site prior to incision
Preincision Marcaine
This group will receive marcaine injection at the study port site prior to incision
Intervention: 0.25% bupivicaine will be injected at the study port site prior to incision
Postincision Placebo
This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure
Intervention: 0.25% bupivicaine will be injected at the study port site prior to incision
Postincision Placebo
This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure
Intervention: Saline will be in injected into the port site prior to closure
Postincision marcaine
This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure
Intervention: 0.25% bupivicaine will be injected at the study port site prior to incision
Postincision marcaine
This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure
Intervention: 0.25% bupivicaine will be injected into the port site prior to closure
Outcomes
Primary Outcomes
Reduction in post-operative pain at large lateral port sites
Time Frame: 4 and 24 hours after surgery
visual analog scoring of post-operative pain in a control and a treatment group