NCT01452633

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

Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	0.25% bupivicaine will be injected at the study port site prior to incision	Injection will precede the incision
DRUG	Saline will be injected at the study port site prior to incision	Injection will precede incision
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
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

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-10-17
• Last updated: 2013-06-10

Locations

1 site across 1 country: United States