Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair

NCT ID: NCT04227912

Last Updated: 2020-01-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2019-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inguinal Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group TAP

Ultrasound-guided TAP Block

Group Type ACTIVE_COMPARATOR

Transversus abdominis plane block

Intervention Type OTHER

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

Group Local

Ultrasound-guided Local Infiltration

Group Type ACTIVE_COMPARATOR

Local anesthetic infiltration

Intervention Type OTHER

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

Group Dexketoprofen

Intravenous Dexketoprofen

Group Type ACTIVE_COMPARATOR

Intravenous dexketoprofen

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transversus abdominis plane block

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

Intervention Type OTHER

Local anesthetic infiltration

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

Intervention Type OTHER

Intravenous dexketoprofen

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fikret Salık

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fikret Salık

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences Gazi Yaşargil Training and Research Hospital

Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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 RESULT
PMID: 21928388 (View on PubMed)

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.

Reference Type RESULT
PMID: 23549122 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://insights.ovid.com/

European Journal of Anaesthesiology

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SBUGaziYasargilTRH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.