Ilioinguinal Nerve BlockNCT04295629
The Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients in Inguinal Hernia With Spinal Anesthesia
A study testing Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia and Ilioinguinal nerve block in people with Ilioinguinal Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Regional anesthesia is a popular anesthetic method in patients who will undergo an inguinal hernia operation. Researchers known that pain in the operating area is a complaint that impairs the quality of life for patients in the long term after the operation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ilioinguinal Nerve Block
- What is being tested?
- Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia and Ilioinguinal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 31 Dec 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age 18-65
- Inguinal hernia operation with spinal anesthesia
- Patients who agreed to participate in the study
Who cannot join
- Mental retards and communication disorder
- Infection at the injection site
- Patient with a clotting disorder
- Local anesthetic allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Bursa
About this study
Official title: Research on the Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients Who Undergo Inguinal Hernia With Spinal Anesthesia
Regional anesthesia is a popular anesthetic method in patients who will undergo an inguinal hernia operation. Researchers known that pain in the operating area is a complaint that impairs the quality of life for patients in the long term after the operation. In addition to regional anesthesia, has planned to investigate the effects of applying another drug near the surgery area on pain that may develop in the long term.
Read the detailed description
Post-operative chronic pain can be defined as the neuropathic-characterized pain persisting at least 3 months after the surgery despite healing of the operation area.
However, it is still uncertain if the underlying physio-pathologic mechanism is due to intraoperative direct nerve injury or it is resulting from indirect nerve injury caused by inflammatory mesh. Post-operative chronic pain restricts the daily activities, causes anxiety and depression, increases use of analgesics and imposes a serious economic burden by increased use of health services and medical treatment. For this reason, today post-operative chronic pain is considered as an important complication of surgery. Researchers can list the risk factors of pain development as; age, weight, preoperative and postoperative pain, surgical method, recurrence, anesthesia method. Various oral non-steroid and/or opioid agents have been used in chronic pain treatment but nowadays interest in regional anesthesia approaches is increasing due to increased systemic side effects. Aim in this study is to evaluate the effects of postoperative ilioinguinal block implementation on chronic pain in patients who will undergo inguinal hernia operation with spinal anesthesia.
- Conditions
- Ilioinguinal Nerve Block
- Being tested
- Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia, Ilioinguinal nerve block
- Keywords
- Inguinal hernia, Ilioinguinal nerve block, Chronic Pain
- Medical subject headings
- Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal AnesthesiaProcedure or surgery
Also called Spinal Anesthesia
The patients underwent inguinal hernia operation randomly classified into two groups in the operating room as; Group I (n:30); spinal block (SA): All patients were given SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space. Times when the block reached T10 level were recorded.
Ilioinguinal nerve blockProcedure or surgery
Group 2 (n:30); SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space and as a ilioinguinal block (IHNB) 10 ml 5% bupivacaine was injected to patients with peripheric nerve block injection in the reanimation unit after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| VAS (Visüel Analog Score) | Active comparator | VAS : 0-10 points 0 means: no pain 10 means: incredible pain Receives: Procedure: Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia; Procedure: Ilioinguinal nerve block |
| LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) | Active comparator | LANSS 0-24 points >12 points : has chronic neuropathic pain <12 points: no chronic neuropathic pain Receives: Procedure: Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia; Procedure: Ilioinguinal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute pain scores( VAS)
Presence of pain was interrogated in the hospital within the first 24 hours (2nd, 6th, 12th, 24th hours), Visüel Analog Scale (VAS) is between 0-10 points, 0 means no pain and 10 means incredible pain.
Measured: 24 hours
chronic pain scores(LANSS)
The presence of pain that may occur in the 3rd and 6th months can be learned by contacting patients by phone. The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is a neuropathic pain scale. In LANSS follow-ups, 12 points or more were associated with neuropathic pain.
Measured: 6 months
Secondary outcomes (3)
taken amount of analgesic drugs
compared how many milligram analgesic agents are given to the patient will be followed.
Measured: 48 hours
postoperative complications
compared complications such as nausea, vomiting, motor or sensorial disorder after 48 hours of operation
Measured: 48 hours
hospital stay
compared how many days patients stayed in the hospital until they were discharged
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Apr 2017
- Primary completion31 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ilioinguinal Nerve BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 ASA I-III patients between ages 18-65 who underwent single-sided inguinal hernia operation were randomly classified into two groups in the operating room as; Group I (n:30); spinal block (SA), Group 2 (n:30); SA and ilioinguinal block (IHNB). All patients were given SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space. Times when the block reached T10 level were recorded. Ultrasoundguided ilioinguinal block was implemented and 10 ml 5% bupivacaine was injected to patients in group I with peripheric nerve block injection in the reanimation unit after the surgery.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Tugba Onur, MD, Principal investigator, 2017-17/24
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295629
- Sponsor's protocol ID
- 2017-17/24
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients Who Undergo Inguinal Hernia With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04295629
- Acronym / sponsor ID
- 2017-17/24
- Conditions
- Ilioinguinal Nerve Block
- Keywords
- Inguinal hernia, Ilioinguinal nerve block, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 Mar 2020 (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.
Regional anesthesia is a popular anesthetic method in patients who will undergo an inguinal hernia operation. Researchers known that pain in the operating area is a complaint that impairs the quality of life for patients in the long term after the operation. In addition to regional anesthesia, has planned to investigate the effects of applying another drug near the surgery area on pain that may develop in the long term.
Detailed description
Post-operative chronic pain can be defined as the neuropathic-characterized pain persisting at least 3 months after the surgery despite healing of the operation area.
However, it is still uncertain if the underlying physio-pathologic mechanism is due to intraoperative direct nerve injury or it is resulting from indirect nerve injury caused by inflammatory mesh. Post-operative chronic pain restricts the daily activities, causes anxiety and depression, increases use of analgesics and imposes a serious economic burden by increased use of health services and medical treatment. For this reason, today post-operative chronic pain is considered as an important complication of surgery. Researchers can list the risk factors of pain development as; age, weight, preoperative and postoperative pain, surgical method, recurrence, anesthesia method. Various oral non-steroid and/or opioid agents have been used in chronic pain treatment but nowadays interest in regional anesthesia approaches is increasing due to increased systemic side effects. Aim in this study is to evaluate the effects of postoperative ilioinguinal block implementation on chronic pain in patients who will undergo inguinal hernia operation with spinal anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 ASA I-III patients between ages 18-65 who underwent single-sided inguinal hernia operation were randomly classified into two groups in the operating room as; Group I (n:30); spinal block (SA), Group 2 (n:30); SA and ilioinguinal block (IHNB). All patients were given SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space. Times when the block reached T10 level were recorded. Ultrasoundguided ilioinguinal block was implemented and 10 ml 5% bupivacaine was injected to patients in group I with peripheric nerve block injection in the reanimation unit after the surgery.
| Arm | Type | Receives |
|---|---|---|
| VAS (Visüel Analog Score) | Active comparator | Procedure: Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia, Procedure: Ilioinguinal nerve blockVAS : 0-10 points 0 means: no pain 10 means: incredible pain |
| LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) | Active comparator | Procedure: Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia, Procedure: Ilioinguinal nerve blockLANSS 0-24 points >12 points : has chronic neuropathic pain <12 points: no chronic neuropathic pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- Age 18-65
- Inguinal hernia operation with spinal anesthesia
- Patients who agreed to participate in the study
Key exclusion criteria (4 listed)
- Mental retards and communication disorder
- Infection at the injection site
- Patient with a clotting disorder
- Local anesthetic allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal AnesthesiaAlso: Spinal AnesthesiaThe patients underwent inguinal hernia operation randomly classified into two groups in the operating room as; Group I (n:30); spinal block (SA): All patients were given SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space. Times when the block reached T10 level were recorded. | Procedure or surgery | LANSS (Leeds Assessment of Neuropathic Symptoms and Signs), VAS (Visüel Analog Score) |
| Ilioinguinal nerve blockGroup 2 (n:30); SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space and as a ilioinguinal block (IHNB) 10 ml 5% bupivacaine was injected to patients with peripheric nerve block injection in the reanimation unit after the surgery. | Procedure or surgery | LANSS (Leeds Assessment of Neuropathic Symptoms and Signs), VAS (Visüel Analog Score) |
Primary outcome
acute pain scores( VAS)
Time frame: 24 hours
Presence of pain was interrogated in the hospital within the first 24 hours (2nd, 6th, 12th, 24th hours), Visüel Analog Scale (VAS) is between 0-10 points, 0 means no pain and 10 means incredible pain.
chronic pain scores(LANSS)
Time frame: 6 months
The presence of pain that may occur in the 3rd and 6th months can be learned by contacting patients by phone. The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is a neuropathic pain scale. In LANSS follow-ups, 12 points or more were associated with neuropathic pain.
3 secondary outcomes
taken amount of analgesic drugs
Time frame: 48 hours
postoperative complications
Time frame: 48 hours
hospital stay
Time frame: 48 hours
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 4 Mar 2020.
- Individual participant dataSharing planned: No
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.
Tugba Onur, MD principal investigator
2017-17/24
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia and Ilioinguinal nerve block in people with Ilioinguinal Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 4 inclusion and 4 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 4 Mar 2020. 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?
acute pain scores( VAS) (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 4 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.