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

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05847842
Collaborator
(none)
90
2
3
24
45
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anterior quadratus lumborum block
  • Procedure: Transversus abdominis plane block
  • Procedure: Local infiltration
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group Q

Anterior quadratus lumborum block

Procedure: Anterior quadratus lumborum block
20 mL of 0.25% bupivacaine will be given

Active Comparator: Group T

Transversus abdominis plane block

Procedure: Transversus abdominis plane block
20 mL of 0.25% bupivacaine will be given

Active Comparator: Group L

Local infiltration

Procedure: Local infiltration
20 mL of 0.25% bupivacaine will be given

Outcome Measures

Primary Outcome Measures

  1. Quality of recovery assessed by Quality of recovery scale (QoR-15) [Postoperative 24th hour.]

    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

  1. Postoperative pain assessed by Numerical Rating Scale (NRS) [At the 2nd, 6th, 12th, 24th and 36th hours]

    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)

  2. Postoperative chronic pain assessed by Numerical Rating Scale (NRS) [Three months later the operation date]

    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).

  3. Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale. [Three months later the operation date]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskisehir Osmangazi University Faculty of Medicine Eskisehir Turkey 26040
2 Eskisehir Osmangazi Universty Eskişehir Turkey 26040

Sponsors and Collaborators

  • Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Gulay Erdogan Kayhan, Prof Dr, Eskisehir Osmangazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gulay ERDOGAN KAYHAN, Professor Doctor, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT05847842
Other Study ID Numbers:
  • ESOGUhernia
First Posted:
May 8, 2023
Last Update Posted:
May 8, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2023