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

NCT04295629 | Completed

• 1 other identifier: 2017-17/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ilioinguinal Nerve Block

Keywords

Inguinal hernia; Ilioinguinal nerve block; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (3)

• taken amount of analgesic drugs

  48 hours

• postoperative complications

  48 hours

• hospital stay

  48 hours

Study Arms (2)

VAS (Visüel Analog Score)

ACTIVE COMPARATOR

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

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

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

Interventions

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

Also known as: Spinal Anesthesia

LANSS (Leeds Assessment of Neuropathic Symptoms and Signs); VAS (Visüel Analog Score)

Ilioinguinal nerve block 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); VAS (Visüel Analog Score)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Mental retards and communication disorder
• Infection at the injection site
• Patient with a clotting disorder
• Local anesthetic allergy

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal; Chronic Pain

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Tugba Onur, MD

  2017-17/24

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle İnvestigator

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 4, 2020
• Study Start: April 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)