NCT02030223

Brief Summary

This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

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

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

3.9 years

First QC Date

January 7, 2014

Last Update Submit

February 16, 2018

Conditions

Inguinal HerniaAbdominal Wall MusclesRegional AnesthesiaPostoperative Pain

Keywords

transversus abdominis plane blockinguinal hernia repairacute postoperative painneuropathic pain

Outcome Measures

Primary Outcomes (1)

  • Pain scores at rest and with movement using the numerical rating scale (NRS)

    3, 6 and 24 hours postoperatively

Secondary Outcomes (1)

  • Incidence of chronic pain

    6 months after surgery

Other Outcomes (1)

  • Morphine consumption (mg)

    24 hours postoperatively

Study Arms (2)

Transversus abdominis plane block with 20 ml ropivacaine 0,75%

ACTIVE COMPARATOR

Transversus abdominis plane block with 20 ml ropivacaine 0,75%

Procedure: Transversus abdominis plane block

Transversus abdominis plane block with 20 ml saline

PLACEBO COMPARATOR

Transversus abdominis plane block with 20 ml saline

Procedure: Transversus abdominis plane block

Interventions

Transversus abdominis plane blockPROCEDURE

ultrasound guided transversus abdominis plane block

Transversus abdominis plane block with 20 ml ropivacaine 0,75%Transversus abdominis plane block with 20 ml saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III patients undergoing inguinal hernia repair with a mesh
  • age between 18 and 75 years old
  • ability to read and write greek

You may not qualify if:

  • Inability to consent to the study
  • BMI \>40kg/m2
  • Skin infection at the puncture site
  • Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
  • Preoperative use of opioids or NSAID's for chronic pain conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieion University Hospital

Athens, Greece

Location

Related Publications (2)

  • Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.

    PMID: 23160979RESULT

  • Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.

    PMID: 23549122RESULT

Related Links

MeSH Terms

Conditions

Hernia, InguinalPain, PostoperativeNeuralgia

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Erifyli Argyra, MD, PhD

    Aretaieion University Hospital

    STUDY CHAIR

  • Kassiani Theodoraki, MD, PhD

    Aretaieion University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 8, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

GR(1)