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Postoperative PainNCT06674213

Comparison of Three Nerve Blocks in Terms of Post-operative Pain in Inguinal Hernia Operations

An observational study of Postoperative Pain, run by Erzincan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Postoperative Pain
How many people
3 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Apr 2023to 3 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erzincan Unıversitesi

    Erzincan, Merkez, 24100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Ilioinguinal/Iliohypogastric Nerve Block, Erector Spine Nerve Block and Retrolaminar Nerve Block in Terms of Post-operative Pain in Inguinal Hernia Operations

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.

Read the detailed description

This observational clinical study was conducted on the General Surgery operating table in Erzincan Mengücek Gazi Training and Research Hospital operating room between 3 April and 3 October 2023, after receiving approval from Erzincan Binali Yıldırım University Faculty of Medicine Ethics Committee dated 30.03.2023 and decision number 2023-07/8. Patients planned to be included in the study were included in the study after they were informed about the study and their consent was obtained.

Criteria for inclusion in the study:

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

Exclusion criteria:

  • Patients with ASA risk score of 3 and above
  • Patients who underwent Recurrent Inguinal Hernia operation
  • Patients who underwent Bilateral Inguinal Hernia operation
  • 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

Power analysis was performed by examining sample articles. As the sample size: When Type 1 error (α) = 0.005 and power (1-β) = 0.80 were selected, 3 groups (Group 1: Ilioinguinal-iliohypogastric nerve block; Group 2: Erector spine nerve block; Group 3: Retrolaminar nerve block) In this study, postoperative pain scores will be compared; When the effect size (Cohen -f) = 0.25 was taken, a total of 159 people were included in the study, 53 people in each group, according to one-way analysis of variance. However, since our study was a follow-up study, a total of 174 people were included in the study with a loss prediction of 10%, taking into account the losses. Data analysis was done in IBM SPSS 25.0 (SPSS Inc., Chicago, IL, USA) package program.

After the patients were taken to the operating table, standard ASA monitoring (electrocardiogram, non-invasive blood pressure, O2 saturation, body temperature) was applied. All patients underwent spinal anesthesia. 174 patients between the ages of 18-60, with ASA I-II, were included in the study after the surgical procedure was completed after anesthesia application. The demographic characteristics of the patients to be included in each group were shown to be similar and they were included in the group. Esaote MyLab™ Six was used as USG in all blocks. In Group I patients, under USG guidance, a high-frequency linear USG probe was placed on the imaginary line connecting the SIAS (spina iliaca anterior superior) and umbilicus in the supine position. The ilioinguinal/iliohypogastric nerves were scanned with USG until they were seen in the fascia between the internal oblique muscle and the transversus abdominis muscle. Visualization of the Circumflex Iliac Artery in the intermuscular fascia was considered as another anatomical landmark to confirm that we were in the correct injection plane. After the injection site was determined, the block needle was entered into the USG in plane at an angle of approximately 30-45 degrees in the craniocaudal direction, it was confirmed that it was not in the intravenous area with negative pressure, and local anesthetic was injected and its spread was monitored. In the Lumbar region ESPB, the high-frequency linear probe was placed parasagittally 3-5 cm lateral to the median line (spinous processes) in Group II patients in the prone position under USG guidance to visualize the transverse processes. After the transverse protrusion was seen, the needle was entered into the skin by giving the probe an angle of approximately 30-45 degrees in the craniocaudal direction. The application site was determined as the fascia between the erector spinae muscle and the transverse process. In-plane technique, after the needle touched the posterior end edge of the transverse process, it was confirmed that it was not in the intravenous area with negative pressure. Then, its distribution was visualized with ultrasonography (USG). The procedure was completed by observing the local anesthetic distribution in the craniocaudal direction. After visualizing the spinous processes in the lumbar region with a high-frequency linear probe in the prone position of Group III patients under USG guidance, the probe was advanced 1-2 cm laterally and the laminae were visualized in the parasagittal plane. After the retrolaminar region was determined, the block needle was entered into the USG in plane, at an angle of approximately 30-45 degrees in the craniocaudal direction. After contacting the lamina and confirming that it was not in the intravenous area with negative pressure, local anesthetic was injected and its spread was monitored. Pain scores were evaluated with a 10-scale VAS scale (0: No pain; 10: The most severe pain) at 0, 4, 12, and 24 hours after surgery. In the postoperative period, the need for additional analgesics, VAS values and other complications were recorded. Data were obtained from anesthesia records and patients were followed with a data tracking form from the operating room.

Keywords
Pain, Postoperative, Hernia, Inguinal, erector spinae plane block, retrolaminar block, Ilioinguinal/iliohypogastric nerve
Medical subject headings
Pain, Postoperative, Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06674213
Study groupRoleWhat they receive
Grup I-İlioinguinal/İliohipogastrik Nerve BlockIlioinguinal/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 BlockErector 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 BlockRetrolaminar 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start3 Apr 2023
  3. Primary completion3 Oct 2023
  4. Study completion3 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674213
Sponsor's protocol ID
ErzincanU-ANESTEZİ-DO-01
Status last verified
Nov 2024
First submitted
14 Oct 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by Erzincan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) (time frame: 24 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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