Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

NCT ID: NCT03968523

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2020-06-29

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two randomized cohorts of treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Each patient will be included in one cohort of treatment by a randomized criteria.

Study Groups

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TAP block

TAP block technique.

Group Type ACTIVE_COMPARATOR

TAP block

Intervention Type PROCEDURE

TAP block technique

Novel local infiltration technique

Local analgesic infiltration in the mesh fixation site

Group Type EXPERIMENTAL

Novel local infiltration technique

Intervention Type PROCEDURE

Local analgesic infiltration in the mesh fixation site

Interventions

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Novel local infiltration technique

Local analgesic infiltration in the mesh fixation site

Intervention Type PROCEDURE

TAP block

TAP block technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years or more.
* Programmed inguinal laparoscopic hernioplasty

Exclusion Criteria

* Allergic to medication prescribed
* Story of mesh rejection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Santiago Bertone, MD

Role: PRINCIPAL_INVESTIGATOR

Surgeon

Locations

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Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type BACKGROUND
PMID: 9164809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15515112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21928388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18020088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21154380 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/9164809

Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. N Engl J M

https://www.ncbi.nlm.nih.gov/m/pubmed/15515112/

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.

https://www.ncbi.nlm.nih.gov/pubmed/21928388

Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. d

https://www.ncbi.nlm.nih.gov/pubmed/18020088

Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.

https://www.ncbi.nlm.nih.gov/pubmed/21154380

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.

Other Identifiers

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3467

Identifier Type: -

Identifier Source: org_study_id

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