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

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.

Study Overview

• Status: Completed
• Conditions: Ilioinguinal Nerve Block
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey
    • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VAS (Visüel Analog Score); 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; 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.; Other Names: Spinal Anesthesia; 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.
Active Comparator: LANSS (Leeds Assessment of Neuropathic Symptoms and Signs); 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; 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.; Other Names: Spinal Anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
taken amount of analgesic drugs	compared how many milligram analgesic agents are given to the patient will be followed.	48 hours
postoperative complications	compared complications such as nausea, vomiting, motor or sensorial disorder after 48 hours of operation	48 hours
hospital stay	compared how many days patients stayed in the hospital until they were discharged	48 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Tugba Onur, MD, 2017-17/24

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Pain; Inguinal hernia; Ilioinguinal nerve block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2017-17/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No