Effect of TAP Block on Ventilatory Function Following Abdominal Surgery

Laparotomy Clinical Trial

— KTAP  

Official title:

Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01719796
• Other study ID #: KTAP
• Status: Recruiting
• Phase: Phase 2
• First received: October 24, 2012
• Last updated: October 30, 2012
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2012
• Source: Pierre and Marie Curie University
• Contact: Mathieu RAUX, MD, PhD
• Phone: +33142177379
• Email: mathieu.raux[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Drug Safety National Agency
• Study type: Interventional

Clinical Trial Summary

Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• laparotomy

Exclusion Criteria:

• below 18, pregnancy, prisoners

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparotomy

Intervention

Procedure:
• Regional analgesia infusion

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vital capacity		72h	No
Secondary	maximum forced expiratory flow		72h	No
Secondary	analgesic consumption		72h	No
Secondary	pain	resting pain, assessed using VAS	72h	No
Secondary	diaphragmatic course	using ultrasonography	72h	No