Clinical trial NCT04295629: The Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients in Inguinal Hernia With Spinal Anesthesia
Official title: Research on the Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients Who Undergo Inguinal Hernia With Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ilioinguinal Nerve Block
Keywords: Inguinal hernia
Ilioinguinal nerve block
Chronic Pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: acute pain scores( VAS)
timeFrame: 24 hours
measure: chronic pain scores(LANSS)
timeFrame: 6 months
Secondary outcomes:
measure: taken amount of analgesic drugs
timeFrame: 48 hours
measure: postoperative complications
timeFrame: 48 hours
measure: hospital stay
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Study officials:
affiliation: 2017-17/24
name: Tugba Onur, MD
role: PRINCIPAL_INVESTIGATOR
References: