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OpenTrials
Completed

NCT Number: NCT01054469

Transversus Abdominus Plane Block

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.

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Key information

Conditions

Nephrectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP block placement with placebo

Procedure

20 ml of normal saline (placebo)

Placement of block with ropivacaine

Procedure

20 ml of 0.5% ropivacaine hydrochloride

Primary outcomes

  1. Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. 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

    Time frame: 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 22, 2010
Registry last updated
Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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