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Comparison of Local Anesthetic Infiltration and Different Fascial Plane Blocks in Inguinal Hernia Repair

Primary Purpose

Postoperative Pain, Inguinal Hernia, Local Infiltration

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anterior quadratus lumborum block
Transversus abdominis plane block
Local infiltration
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia American Society of Anesthesiology (ASA) physical classification I-III Exclusion Criteria: Patients who will undergo laparoscopic surgery Previous inguinal hernia repair surgery A history of opioid use or pain management Coagulopathy or anticoagulant use Patients who have difficulty communicating or who are not cooperative

Sites / Locations

  • Eskisehir Osmangazi University Faculty of MedicineRecruiting
  • Eskisehir Osmangazi UniverstyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group Q

Group T

Group L

Arm Description

Anterior quadratus lumborum block

Transversus abdominis plane block

Local infiltration

Outcomes

Primary Outcome Measures

Quality of recovery assessed by Quality of recovery scale (QoR-15)
The 15-item quality of recovery (QoR-15) scale is a questionnaire used to evaluate the postoperative recovery quality of patients in the early postoperative stages. The QoR-15 score comprises 15 questions that assess 5 recovery domains, namely, physical comfort, physical independence, psychological support, emotional status, and pain. Each question is scored from 0 to 10 (0 none of the time to 10 all of the time).

Secondary Outcome Measures

Postoperative pain assessed by Numerical Rating Scale (NRS)
Postoperative pain levels during rest and movement (from supine to sitting position) will be evaluated by Numerical rating scale (0-no pain; 10-unbearable pain)
Postoperative chronic pain assessed by Numerical Rating Scale (NRS)
Patients will be called by phone and the presence of chronic pain will be questioned with the Numerical Rating Scale (0-no pain; 10-unbearable pain).
Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.
Patients will be called by phone and the presence of neuropathic pain pain will be questioned with the Douleur neuropathic pain (DN4) scale. The items of the DN4 are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10.

Full Information

First Posted
April 18, 2023
Last Updated
May 4, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05847842
Brief Title
Comparison of Local Anesthetic Infiltration and Different Fascial Plane Blocks in Inguinal Hernia Repair
Official Title
Comparison of the Effects of Local Anesthetic Infiltration and Different Fascial Plane Blocks on Postoperative Recovery Quality and Pain in Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

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

5. Study Description

Brief Summary
In this study, quadratus lumborum block (QLB), transversus abdominis plane (TAP) block, and local anesthetic infiltration will be performed preoperatively in patients who will undergo unilateral inguinal herniorrhaphy operation under general anesthesia. Quality of recovery (QoR-15) score, postoperative acute and chronic pain levels will be evaluated.
Detailed Description
Inguinal hernia repair, one of the most common operations, causes moderate to severe postoperative pain. The postoperative pain delays patients' recovery and return to daily life, increases the rate of readmission to the hospital, and can lead to persistent postoperative pain.Procedure-specific postoperative pain management (PROSPECT) recommendations for optimal pain management have been recently updated. Accordingly, in addition to preoperative or intraoperative paracetamol and nonsteroidal anti-inflammatory analgesics, local anesthetic infiltration and/or regional analgesia techniques (ilio-inguinal nerve blocks or TAP block) with rescue opioids are recommended. Also, it has been reported that further research is needed on new regional techniques (other fascial plane blocks etc).It has been shown that QLB potentially results in extensive sensory blockade (T7-12), and in cadaver studies, the iliohypogastric and ilioinguinal nerves are constantly involved. In addition, there are studies suggesting that it provides much longer analgesia than TAP block. There are few studies on its efficacy in inguinal hernia repair that are in pediatric cases or performed in addition to central blocks. It is hypothesized that QLB may provide better and longer analgesia, may increase the quality of recovery and reduce the development of resistant chronic pain, compared to other regional methods such as local infiltration or TAP block, that proven effectiveness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inguinal Hernia, Local Infiltration, Quality of Recovery, Quadratus Lumborum Block, Transversus Abdominis Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Q
Arm Type
Active Comparator
Arm Description
Anterior quadratus lumborum block
Arm Title
Group T
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block
Arm Title
Group L
Arm Type
Active Comparator
Arm Description
Local infiltration
Intervention Type
Procedure
Intervention Name(s)
Anterior quadratus lumborum block
Intervention Description
20 mL of 0.25% bupivacaine will be given
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
20 mL of 0.25% bupivacaine will be given
Intervention Type
Procedure
Intervention Name(s)
Local infiltration
Intervention Description
20 mL of 0.25% bupivacaine will be given
Primary Outcome Measure Information:
Title
Quality of recovery assessed by Quality of recovery scale (QoR-15)
Description
The 15-item quality of recovery (QoR-15) scale is a questionnaire used to evaluate the postoperative recovery quality of patients in the early postoperative stages. The QoR-15 score comprises 15 questions that assess 5 recovery domains, namely, physical comfort, physical independence, psychological support, emotional status, and pain. Each question is scored from 0 to 10 (0 none of the time to 10 all of the time).
Time Frame
Postoperative 24th hour.
Secondary Outcome Measure Information:
Title
Postoperative pain assessed by Numerical Rating Scale (NRS)
Description
Postoperative pain levels during rest and movement (from supine to sitting position) will be evaluated by Numerical rating scale (0-no pain; 10-unbearable pain)
Time Frame
At the 2nd, 6th, 12th, 24th and 36th hours
Title
Postoperative chronic pain assessed by Numerical Rating Scale (NRS)
Description
Patients will be called by phone and the presence of chronic pain will be questioned with the Numerical Rating Scale (0-no pain; 10-unbearable pain).
Time Frame
Three months later the operation date
Title
Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.
Description
Patients will be called by phone and the presence of neuropathic pain pain will be questioned with the Douleur neuropathic pain (DN4) scale. The items of the DN4 are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10.
Time Frame
Three months later the operation date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia American Society of Anesthesiology (ASA) physical classification I-III Exclusion Criteria: Patients who will undergo laparoscopic surgery Previous inguinal hernia repair surgery A history of opioid use or pain management Coagulopathy or anticoagulant use Patients who have difficulty communicating or who are not cooperative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gizem Cetinkaya, MD
Phone
905056439790
Email
gizem.ctnky@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulay Erdogan Kayhan, Prof Dr
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University Faculty of Medicine
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulay Erdogan Kayhan, Prof.
Phone
905332560011
Email
drgulayer@yahoo.com
Facility Name
Eskisehir Osmangazi Universty
City
Eskişehir
ZIP/Postal Code
26040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulay Erdogan Kayhan, Prof Dr
Phone
905332560011
Email
drgulayer@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34537121
Citation
Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.
Results Reference
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Comparison of Local Anesthetic Infiltration and Different Fascial Plane Blocks in Inguinal Hernia Repair

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