Recruiting

Local Anesthesia

Sponsor:

Stony Brook University

Code:

NCT01452633

Conditions

Post Operative Pain

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Accepted

Interventions

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

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

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

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

Study Details

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.

Conditions

Post Operative Pain

Study ID

NCT01452633

Start date

Nov, 2011

Status verified date

Jun, 2013

Completion date

May, 2014

Anticipated

Primary completion date

May, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • patients undergoing laparoscopic surgery

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Preincision Placebo

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

active comparator: Preincision Marcaine

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

placebo comparator: Postincision Placebo

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

active comparator: Postincision marcaine

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

Interventions

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

Primary outcome measure

  • Reduction in post-operative pain at large lateral port sites [ Time Frame: 4 and 24 hours after surgery ]

Central Contacts and Locations

Locations

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

James N Droesch, MD

631-444-2757james.droesch@sbumed.org

Todd Griffin, MD

6314442757todd.griffin@sbumed.org

Principal Investigator:

James N Droesch, MD

More Information

Sponsor

Stony Brook University

Last update posted

Jun 10, 2013

Last verified

Jun, 2013

Keywords

  • pain
  • laparoscopy
  • reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2013-06-10.