Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
- Conditions
- Post Operative Pain
- Interventions
- Drug: Saline will be injected at the study port site prior to incisionDrug: 0.25% bupivicaine will be injected at the study port site prior to incisionDrug: Saline will be in injected into the port site prior to closureDrug: 0.25% bupivicaine will be injected into the port site prior to closure
- Registration Number
- NCT01452633
- Lead Sponsor
- Stony Brook University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- patients undergoing laparoscopic surgery
- Cardiovascular instability
- malignancies
- pulmonary conditions incompatible with laparoscopic surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preincision Placebo Saline will be injected at the study port site prior to incision This group of patients will receive saline injection at study port site before incision Preincision Marcaine 0.25% bupivicaine will be injected at the study port site prior to incision This group will receive marcaine injection at the study port site prior to incision Postincision Placebo 0.25% bupivicaine will be injected 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 Postincision Placebo Saline will be in injected into the port site prior to closure This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure Postincision marcaine 0.25% bupivicaine will be injected at the study port site prior to incision This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure Postincision marcaine 0.25% bupivicaine will be injected into the port site prior to closure This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States