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

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.

Study Overview

• Status: Unknown
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Saline will be injected at the study port site prior to incision; Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Drug: Saline will be in injected into the port site prior to closure; Drug: 0.25% bupivicaine will be injected into the port site prior to closure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Medical Center
      • Contact: James N Droesch, MD; Phone Number: 631-444-2757; Email: james.droesch@sbumed.org
      • Contact: Todd Griffin, MD; Phone Number: 6314442757; Email: todd.griffin@sbumed.org
      • Principal Investigator: James N Droesch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients undergoing laparoscopic surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Preincision Placebo; This group of patients will receive saline injection at study port site before incision	Drug: Saline will be injected at the study port site prior to incision; Injection will precede incision; Other Names: normal saline
Active Comparator: Preincision Marcaine; This group will receive marcaine injection at the study port site prior to incision	Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Injection will precede the incision; Other Names: marcaine
Placebo Comparator: Postincision Placebo; This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure	Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Injection will precede the incision; Other Names: marcaine; 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
Active Comparator: Postincision marcaine; This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure	Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Injection will precede the incision; Other Names: marcaine; 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; Other Names: marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: James N Droesch, MD, Stony Brook University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: pain; laparoscopy; reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 241577-1