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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847842
• Other study ID #: ESOGUhernia
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2023
• Source: Eskisehir Osmangazi University
• Contact: Gizem Cetinkaya, MD
• Phone: 905056439790
• Email: gizem.ctnky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Local Infiltration
• Postoperative Pain
• Quadratus Lumborum Block
• Quality of Recovery
• Transversus Abdominis Plane Block

Intervention

Procedure:
• Anterior quadratus lumborum block
20 mL of 0.25% bupivacaine will be given
• Transversus abdominis plane block
20 mL of 0.25% bupivacaine will be given
• Local infiltration
20 mL of 0.25% bupivacaine will be given

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Faculty of Medicine	Eskisehir
Turkey	Eskisehir Osmangazi Universty	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Postoperative 24th hour.
Secondary	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)	At the 2nd, 6th, 12th, 24th and 36th hours
Secondary	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).	Three months later the operation date
Secondary	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.	Three months later the operation date