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Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Novel local infiltration technique
TAP block
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Laparoscopic inguinal hernioplasty, TAP block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or more.
  • Programmed inguinal laparoscopic hernioplasty

Exclusion Criteria:

  • Allergic to medication prescribed
  • Story of mesh rejection

Sites / Locations

  • Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TAP block

Novel local infiltration technique

Arm Description

TAP block technique.

Local analgesic infiltration in the mesh fixation site

Outcomes

Primary Outcome Measures

Postoperative pain
Postoperative main measured by an visual analogue scale

Secondary Outcome Measures

Analgesics consumption
Time to analgesic consumption
type of analgesic consumption
type of analgesic consumption
pain at the moment of need of analgesics take
pain measured at the analgesic consumption

Full Information

First Posted
May 20, 2019
Last Updated
July 12, 2020
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT03968523
Brief Title
Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty
Official Title
Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
June 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Laparoscopic inguinal hernioplasty, TAP block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomized cohorts of treatment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Each patient will be included in one cohort of treatment by a randomized criteria.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Active Comparator
Arm Description
TAP block technique.
Arm Title
Novel local infiltration technique
Arm Type
Experimental
Arm Description
Local analgesic infiltration in the mesh fixation site
Intervention Type
Procedure
Intervention Name(s)
Novel local infiltration technique
Intervention Description
Local analgesic infiltration in the mesh fixation site
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
TAP block technique
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative main measured by an visual analogue scale
Time Frame
30 days postoperative
Secondary Outcome Measure Information:
Title
Analgesics consumption
Description
Time to analgesic consumption
Time Frame
30 days postoperative
Title
type of analgesic consumption
Description
type of analgesic consumption
Time Frame
30 days
Title
pain at the moment of need of analgesics take
Description
pain measured at the analgesic consumption
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Postoperative complications
Description
Seroma, hematoma, surgical site infection
Time Frame
30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or more. Programmed inguinal laparoscopic hernioplasty Exclusion Criteria: Allergic to medication prescribed Story of mesh rejection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Bertone, MD
Organizational Affiliation
Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9164809
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.
Results Reference
background
PubMed Identifier
15515112
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.
Results Reference
background
PubMed Identifier
21928388
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.
Results Reference
background
PubMed Identifier
18020088
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.
Results Reference
background
PubMed Identifier
21154380
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/9164809
Description
Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. N Engl J M
URL
https://www.ncbi.nlm.nih.gov/m/pubmed/15515112/
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pubmed/21928388
Description
Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. d
URL
https://www.ncbi.nlm.nih.gov/pubmed/18020088
Description
Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.
URL
https://www.ncbi.nlm.nih.gov/pubmed/21154380
Description
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.

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Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

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