The Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients in Inguinal Hernia With Spinal Anesthesia

NCT ID: NCT04295629

Last Updated: 2020-03-04

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Ilioinguinal Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VAS (Visüel Analog Score)

VAS : 0-10 points 0 means: no pain 10 means: incredible pain

Group Type ACTIVE_COMPARATOR

Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia

Intervention Type PROCEDURE

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 block

Intervention Type PROCEDURE

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.

LANSS (Leeds Assessment of Neuropathic Symptoms and Signs)

LANSS 0-24 points \>12 points : has chronic neuropathic pain \<12 points: no chronic neuropathic pain

Group Type ACTIVE_COMPARATOR

Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia

Intervention Type PROCEDURE

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 block

Intervention Type PROCEDURE

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.

Interventions

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Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with 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.

Intervention Type PROCEDURE

Ilioinguinal nerve block

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.

Intervention Type PROCEDURE

Other Intervention Names

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Spinal Anesthesia

Eligibility Criteria

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Inclusion Criteria

* ASA I-III
* Age 18-65
* Inguinal hernia operation with spinal anesthesia
* Patients who agreed to participate in the study

Exclusion Criteria

* Mental retards and communication disorder
* Infection at the injection site
* Patient with a clotting disorder
* Local anesthetic allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tugba Onur

Principle İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tugba Onur, MD

Role: PRINCIPAL_INVESTIGATOR

2017-17/24

Locations

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University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017-17/24

Identifier Type: -

Identifier Source: org_study_id

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