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

NCT ID: NCT01452633

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Preincision Placebo

This group of patients will receive saline injection at study port site before incision

Group Type: PLACEBO_COMPARATOR

Saline will be injected at the study port site prior to incision

Intervention Type: DRUG

Injection will precede incision

Preincision Marcaine

This group will receive marcaine injection at the study port site prior to incision

Group Type: ACTIVE_COMPARATOR

0.25% bupivicaine will be injected at the study port site prior to incision

Intervention Type: DRUG

Injection will precede the incision

Postincision Placebo

This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure

Group Type: PLACEBO_COMPARATOR

0.25% bupivicaine will be injected at the study port site prior to incision

Intervention Type: DRUG

Injection will precede the incision

Saline will be in injected into the port site prior to closure

Intervention Type: DRUG

Saline will be injected into the port site prior to the closure without any preincisional intervention

Postincision marcaine

This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure

Group Type: ACTIVE_COMPARATOR

0.25% bupivicaine will be injected at the study port site prior to incision

Intervention Type: DRUG

Injection will precede the incision

0.25% bupivicaine will be injected into the port site prior to closure

Intervention Type: DRUG

0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention

Interventions

0.25% bupivicaine will be injected at the study port site prior to incision

Injection will precede the incision

Intervention Type: DRUG

Saline will be injected at the study port site prior to incision

Injection will precede incision

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

marcaine; normal saline; marcaine

Eligibility Criteria

Inclusion Criteria

• patients undergoing laparoscopic surgery

Exclusion Criteria

• Cardiovascular instability
• malignancies
• pulmonary conditions incompatible with laparoscopic surgery

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

James Droesch

Associate Professor, Obsterics/Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James N Droesch, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

James N Droesch, MD

Role: primary

james.droesch@sbumed.org

631-444-2757

Todd Griffin, MD

Role: backup

todd.griffin@sbumed.org

6314442757

Other Identifiers

241577-1

Identifier Type: -

Identifier Source: org_study_id