The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Postoperative Pain Clinical Trial

Official title:

The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263963
• Other study ID #: 2013-066
• Secondary ID: DDI.FY13.07
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients over the age of 18 years w

2. Elective laparoscopic colorectal resection.

Exclusion Criteria:

1. Patients under 18 years.

2. Patients unable to provide informed consent

3. Patients undergoing emergency surgery.

4. Pregnant women

5. Severe liver or kidney disease (GFR 15-29 ml/min)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Exparel
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.

Procedure:
• TAP Block
no intervention will be done to this arm.

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative Complications.	Any postoperative complications within 30 days of procedure, including death will be recorded.	participants will be followed for the duration of hospital stay, and 30 days after discharge.
Other	Length of Hospital Stay.	Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.	participants will be followed for the duration of hospital stay, an expected average of 4 days
Primary	Postoperative Pain Score	Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.	participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary	Postoperative Narcotic Use	Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.	participants will be followed for the duration of hospital stay, an expected average of 4 days