NCT03968523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

May 20, 2019

Last Update Submit

July 12, 2020

Conditions

Postoperative Pain

Keywords

Postoperative painLaparoscopic inguinal hernioplastyTAP block

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Postoperative main measured by an visual analogue scale

    30 days postoperative

Secondary Outcomes (3)

  • Analgesics consumption

    30 days postoperative

  • type of analgesic consumption

    30 days

  • pain at the moment of need of analgesics take

    30 days

Other Outcomes (1)

  • Postoperative complications

    30 days postoperative

Study Arms (2)

TAP block

ACTIVE COMPARATOR

TAP block technique.

Procedure: TAP block

Novel local infiltration technique

EXPERIMENTAL

Local analgesic infiltration in the mesh fixation site

Procedure: Novel local infiltration technique

Interventions

Novel local infiltration techniquePROCEDURE

Local analgesic infiltration in the mesh fixation site

Novel local infiltration technique
TAP blockPROCEDURE

TAP block technique

TAP block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or more.
  • Programmed inguinal laparoscopic hernioplasty

You may not qualify if:

  • Allergic to medication prescribed
  • Story of mesh rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1181, Argentina

Location

Related Publications (5)

  • 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.

    PMID: 9164809BACKGROUND

  • 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.

    PMID: 15515112BACKGROUND

  • 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.

    PMID: 21928388BACKGROUND

  • 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.

    PMID: 18020088BACKGROUND

  • 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.

    PMID: 21154380BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Santiago Bertone, MD

    Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each patient will be included in one cohort of treatment by a randomized criteria.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two randomized cohorts of treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 30, 2019

Study Start

April 23, 2019

Primary Completion

June 29, 2020

Study Completion

June 29, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)