Clinical trial NCT03968523: Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty
Official title: Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Laparoscopic inguinal hernioplasty
TAP block
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized cohorts of treatment.
Primary purpose: TREATMENT

Brief summary: Laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. TAP block is the gold standard technique in this type of hernioplasty. Our aim is to compare TAP block with a novel local infiltration technique that uses direct laparoscopical vision.

Detailed description: Laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. TAP block is the gold standard technique in this type of hernioplasty. Our aim is to compare TAP block with a novel local infiltration technique that uses direct laparoscopical vision. Patients will be randomized into two arms of intervention that will be compared by a blind analysis. Primary outcomes will be postoperative pain evaluated systematically until 30 days postoperative, and analgesic consumption.

Eligibility criteria: Inclusion Criteria:

* 18 years or more.
* Programmed inguinal laparoscopic hernioplasty

Exclusion Criteria:

* Allergic to medication prescribed
* Story of mesh rejection

Primary outcomes:
measure: Postoperative pain
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Analgesics consumption
timeFrame: 30 days postoperative
measure: type of analgesic consumption
timeFrame: 30 days
measure: pain at the moment of need of analgesics take
timeFrame: 30 days
Other outcomes:
measure: Postoperative complications
timeFrame: 30 days postoperative
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Surgeon
name: Santiago Bertone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liem MS, van der Graaf Y, van Steensel CJ, Boelhouwer RU, Clevers GJ, Meijer WS, Stassen LP, Vente JP, Weidema WF, Schrijvers AJ, van Vroonhoven TJ. Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. N Engl J Med. 1997 May 29;336(22):1541-7. doi: 10.1056/NEJM199705293362201.
citation: Grant AM, Scott NW, O'Dwyer PJ; MRC Laparoscopic Groin Hernia Trial Group. Five-year follow-up of a randomized trial to assess pain and numbness after laparoscopic or open repair of groin hernia. Br J Surg. 2004 Dec;91(12):1570-4. doi: 10.1002/bjs.4799.
citation: Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
citation: Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
citation: Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.