Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Postoperative Pain Clinical Trial

Official title:

Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968523
• Other study ID #: 3467
• Status: Completed
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: June 29, 2020

Study information

• Verified date: July 2020
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or more.

• Programmed inguinal laparoscopic hernioplasty

Exclusion Criteria:

• Allergic to medication prescribed

• Story of mesh rejection

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Novel local infiltration technique
Local analgesic infiltration in the mesh fixation site
• TAP block
TAP block technique

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

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. Review. Update in: Cochrane Database Syst Rev. 2020 Apr 9;4:CD007705. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications	Seroma, hematoma, surgical site infection	30 days postoperative
Primary	Postoperative pain	Postoperative main measured by an visual analogue scale	30 days postoperative
Secondary	Analgesics consumption	Time to analgesic consumption	30 days postoperative
Secondary	type of analgesic consumption	type of analgesic consumption	30 days
Secondary	pain at the moment of need of analgesics take	pain measured at the analgesic consumption	30 days

External Links

•   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. Review.
•   Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. N Engl J M
•   Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. d
•   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.
•   Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.