NCT04227912

Brief Summary

This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 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

February 11, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

January 8, 2020

Last Update Submit

January 10, 2020

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Postoperative rescue tramadol consumption

    The mean tramadol consumption in the first 24 post-operative hours

    24 hours

Secondary Outcomes (2)

  • Analgesic efficacy

    24 hours

  • Postoperative nausea-vomiting

    24 hours

Study Arms (3)

Group TAP

ACTIVE COMPARATOR

Ultrasound-guided TAP Block

Other: Transversus abdominis plane block

Group Local

ACTIVE COMPARATOR

Ultrasound-guided Local Infiltration

Other: Local anesthetic infiltration

Group Dexketoprofen

ACTIVE COMPARATOR

Intravenous Dexketoprofen

Other: Intravenous dexketoprofen

Interventions

Transversus abdominis plane blockOTHER

Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.

Group TAP
Local anesthetic infiltrationOTHER

Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.

Group Local
Intravenous dexketoprofenOTHER

Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.

Group Dexketoprofen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject who aged 18-75 years
  • American Society of Anesthesiologist (ASA) I-III
  • Subject undergoing unilateral or bilateral inguinal hernia repair

You may not qualify if:

  • Subject under 18 and over 75 years of age
  • ASA IV
  • History of allergy to agents
  • Analgesic drug use in the last 48 hours
  • Morbid obese (BMI\> 35)
  • Confusion
  • Coagulopathy
  • Local infection at the injection site
  • Subject with heart, lung, hematologic, metabolic and endocrine disease
  • Subject who did not want to be included in the study
  • Subject who refused the spinal anesthesia
  • Subject who failed the spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Gazi Yaşargil Training and Research Hospital

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 21928388RESULT

  • 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, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Fikret Salık

    Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 14, 2020

Study Start

February 11, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

TU(1)