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

Ilioinguinal Nerve Block Clinical Trial

Official title:

Research on the Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients Who Undergo Inguinal Hernia With Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295629
• Other study ID #: 2017-17/24
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2020
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Ilioinguinal Nerve Block

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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