NCT01452633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

October 12, 2011

Last Update Submit

June 6, 2013

Conditions

Post Operative Pain

Keywords

painlaparoscopyreduction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Preincision Placebo

PLACEBO COMPARATOR

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

Preincision Marcaine

ACTIVE COMPARATOR

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

Postincision Placebo

PLACEBO COMPARATOR

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

Postincision marcaine

ACTIVE COMPARATOR

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

Interventions

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

Injection will precede the incision

Also known as: marcaine
Postincision PlaceboPostincision marcainePreincision Marcaine
Saline will be injected at the study port site prior to incisionDRUG

Injection will precede incision

Also known as: normal saline
Preincision Placebo
Saline will be in injected into the port site prior to closureDRUG

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

Postincision Placebo
0.25% bupivicaine will be injected into the port site prior to closureDRUG

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

Also known as: marcaine
Postincision marcaine

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing laparoscopic surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • James N Droesch, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Obsterics/Gynecology

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 17, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

US(1)