Transversus Abdominus Plane Block

Nephrectomy Clinical Trial

Official title:

Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054469
• Other study ID #: 08-003563
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: June 20, 2012
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who are = 18 and = 80 years of age.

• Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.

Exclusion Criteria:

• Patients scheduled to undergo an open procedure for nephrectomy

• Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.

• Bilateral nephrectomy

• Pregnant or lactating patients

• Patients unable or unwilling to provide informed consent

• Patients unable to comprehend the use of a visual analog scale

• Patients desiring preemptive antiemetics

• Opioid tolerance

• Allergy to amide local anesthetics or any of the study drugs (morphine).

• Contraindication to regional nerve block (bleeding disorder, infection at site of block)

• Patients with history of dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nephrectomy

Intervention

Procedure:
• TAP block placement with placebo
20 ml of normal saline (placebo)
• Placement of block with ropivacaine
20 ml of 0.5% ropivacaine hydrochloride

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.		24 hours postoperatively	No
Secondary	TAP block with ropivacaine will lead to equivalent or better results with regard to the following outcomes:pain scores, nausea, vomiting, sedation, request for PCA, discontinuation of Foley catheter, discharge from the hospital		24 hours postoperatively	No