Clinical trial NCT05847842: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postoperative Pain
Inguinal Hernia
Local Infiltration
Quality of Recovery
Quadratus Lumborum Block
Transversus Abdominis Plane Block
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of recovery assessed by Quality of recovery scale (QoR-15)
timeFrame: Postoperative 24th hour.
Secondary outcomes:
measure: Postoperative pain assessed by Numerical Rating Scale (NRS)
timeFrame: At the 2nd, 6th, 12th, 24th and 36th hours
measure: Postoperative chronic pain assessed by Numerical Rating Scale (NRS)
timeFrame: Three months later the operation date
measure: Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.
timeFrame: Three months later the operation date
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Faculty of Medicine
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi Universty
Study officials:
affiliation: Eskisehir Osmangazi University
name: Gulay Erdogan Kayhan, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.