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

Primary Purpose

Ilioinguinal Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia
Ilioinguinal nerve block
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ilioinguinal Nerve Block focused on measuring Inguinal hernia, Ilioinguinal nerve block, Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VAS (Visüel Analog Score)

LANSS (Leeds Assessment of Neuropathic Symptoms and Signs)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 29, 2020
Last Updated
March 3, 2020
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04295629
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ilioinguinal Nerve Block
Keywords
Inguinal hernia, Ilioinguinal nerve block, Chronic Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAS (Visüel Analog Score)
Arm Type
Active Comparator
Arm Description
VAS : 0-10 points 0 means: no pain 10 means: incredible pain
Arm Title
LANSS (Leeds Assessment of Neuropathic Symptoms and Signs)
Arm Type
Active Comparator
Arm Description
LANSS 0-24 points >12 points : has chronic neuropathic pain <12 points: no chronic neuropathic pain
Intervention Type
Procedure
Intervention Name(s)
Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia
Other Intervention Name(s)
Spinal Anesthesia
Intervention Description
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
Intervention Name(s)
Ilioinguinal nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
acute pain scores( VAS)
Description
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.
Time Frame
24 hours
Title
chronic pain scores(LANSS)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
taken amount of analgesic drugs
Description
compared how many milligram analgesic agents are given to the patient will be followed.
Time Frame
48 hours
Title
postoperative complications
Description
compared complications such as nausea, vomiting, motor or sensorial disorder after 48 hours of operation
Time Frame
48 hours
Title
hospital stay
Description
compared how many days patients stayed in the hospital until they were discharged
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugba Onur, MD
Organizational Affiliation
2017-17/24
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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