NCT06674213

Brief Summary

The purpose of this study is to compare the postoperative pain of patients who underwent Inguinal Hernia surgery and the differences between 3 different postoperative nerve block techniques on postoperative pain. It will be investigated which block has the higher effect on postoperative pain and can be used to control the patient's pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

October 14, 2024

Last Update Submit

November 4, 2024

Conditions

Keywords

Pain, PostoperativeHernia, Inguinalerector spinae plane blockretrolaminar blockIlioinguinal/iliohypogastric nerve

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    The patient's Pain Score (VAS Scale) will be evaluated at the 0th hour, 4th hour, 12th hour and 24th hour postoperatively. VAS scale; 0: no pain, 10: very severe, unbearable pain. For postoperative patient monitoring, a physician who does not know the type of block applied will evaluate the patients.

    24 Hours

Study Arms (3)

Grup I-İlioinguinal/İliohipogastrik Nerve Block

Ilioinguinal/Iliohypogastric nerve block will be applied under ultrasound guidance. Pain measurements were evaluated 24 hours after surgery. Pain measurement will be evaluated according to the VAS scale.

Grup II-Erektör Spine Nerve Block

Erector spine plane block will be applied under ultrasound guidance. Pain measurements were evaluated 24 hours after surgery. Pain measurement will be evaluated according to the VAS scale.

Grup III-Retrolaminer Nerve Block

Retrolaminar block will be applied under ultrasound guidance. Pain measurements were evaluated 24 hours after surgery. Pain measurement will be evaluated according to the VAS scale.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

159 patients will be included in the study. However, since our study is a follow-up study, a total of 174 patients will be included in the study with a loss prediction of 10%, taking into account the losses. Patients will between the ages of 18-60, who are planned for elective unilateral inguinal hernia surgery by the General Surgery clinic, will be included in the study.

You may qualify if:

  • Having ASA 1 and 2 risk scores
  • Primary unilateral Inguinal Hernia operation was performed
  • Patients between the ages of 18-60

You may not qualify if:

  • Patients with ASA risk score of 3 and above
  • Patients who underwent Recurrent Inguinal Hernia operation
  • Patients who underwent Bilateral Inguinal Hernia surgery
  • Pregnant Patients
  • Those with Neuromuscular Disease
  • Patients with Uncontrolled Diabetes Mellitus
  • Patients who do not accept the study
  • Patients with Cognitive Dysfunction
  • Patients with a history of Local Anesthetic Drug Toxicity
  • Patients with a History of Cerebrovascular Disease
  • Patients with Neurological Dysfunction
  • Patients with Bleeding Diathesis
  • Patients with spinal deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Unıversitesi

Erzincan, Merkez, 24100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeHernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

October 14, 2024

First Posted

November 5, 2024

Study Start

April 3, 2023

Primary Completion

October 3, 2023

Study Completion

October 3, 2023

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations