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).
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.
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted5 Nov 2024
- Study start3 Apr 2023
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM ONK, Erzincan University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06674213
- Acronym / sponsor ID
- ErzincanU-ANESTEZİ-DO-01
- Conditions
- Postoperative Pain
- Keywords
- Pain, Postoperative, Hernia, Inguinal, erector spinae plane block, retrolaminar block, Ilioinguinal/iliohypogastric nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Having ASA 1 and 2 risk scores
- Primary unilateral Inguinal Hernia operation was performed
- Patients between the ages of 18-60
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 24 Hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.