Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

NCT ID: NCT01530815

Last Updated: 2012-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-01-31

Brief Summary

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The investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.

Detailed Description

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The primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. We hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bupivicaine Infusion

We will infuse bupivicaine between the abdominal wall and mesh to try and reduce postoperative pain

Group Type EXPERIMENTAL

Bupivicaine Infusion

Intervention Type DRUG

Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall

Interventions

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Bupivicaine Infusion

Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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Inclusion Criteria

1. Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study
2. Age 18 or older
3. Patient must agree to complete pain journal postoperatively
4. Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal

Exclusion Criteria

1. Any surgical procedure occurring besides the study procedure
2. Any allergy or sensitivity to bupivicaine or its derivatives
3. Less than 18 years of age
4. Patient unable to self report in pain journal due to cognitive disabilities
5. Discharged less than 4 hours post-surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang, Steve S., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve S Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Barbara Cottage Hospital

Locations

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Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Steve Chang, MD

Role: CONTACT

805-637-0217

Facility Contacts

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Steve S Chang, MD

Role: primary

805-637-0217

References

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Gough AE, Chang S, Reddy S, Ferrigno L, Zerey M, Grotts J, Yim S, Thoman DS. Periprosthetic Anesthetic for Postoperative Pain After Laparoscopic Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2015 Sep;150(9):835-40. doi: 10.1001/jamasurg.2015.1530.

Reference Type DERIVED
PMID: 26154700 (View on PubMed)

Other Identifiers

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LapHernia_SBCH

Identifier Type: -

Identifier Source: org_study_id

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