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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01452633
• Other study ID #: 241577-1
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2011
• Last updated: June 6, 2013
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2013
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing laparoscopic surgery

Exclusion Criteria:

• Cardiovascular instability

• malignancies

• pulmonary conditions incompatible with laparoscopic surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in post-operative pain at large lateral port sites	visual analog scoring of post-operative pain in a control and a treatment group	4 and 24 hours after surgery	No