The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

NCT06406959 | Recruiting

• 1 other identifier: 2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The study is devoted to the impact of preemptive regional Transversus abdominal plane block on the postoperative acute and chronic pain after elective Transabdominal preperitoneal (TAPP) inguinal hernia repair.

Conditions

Primary Inguinal Hernia

Keywords

transverse abdominis plane block; inguinal hernia; TAPP technique; chronic postoperative pain; acute pain; inguinal hernia surgery

Outcome Measures

Primary Outcomes (1)

• Acute postoperative pain 4h

  Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.

  4±1 hours postop

Secondary Outcomes (11)

• Acute postoperative pain 2h

  2±1 hours postop

• Acute postoperative pain 6h

  6±1 hours postop

• Number of Participants meeting discharge criteria

  6±1 hours postop

• Analgetic consumption (dose quantity)

  24 hours postop

• Concentration of serum cortisol

  At 8 am on the day of surgery, 4±1 hours postop

Study Arms (2)

TAP-block

EXPERIMENTAL

TAPP inguinal hernia repair under general anesthesia with endotracheal intubation. Patients receive unilateral US-guided TAP-block with 20 ml 0,375% Levobupivacaine before incision

Procedure: Transversus abdominal plane block (TAP block)

Standard care

NO INTERVENTION

TAPP inguinal hernia repair under general anesthesia with endotracheal intubation (without preemptive regional anesthesia) in accordance with actual standard of care.

Interventions

Transversus abdominal plane block (TAP block) PROCEDURE

Unilateral US-guided TAP-block lateral approach with 20 ml 0,375% Levobupivacaine before incision

TAP-block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral primary inguinal hernia who are scheduled for elective Transabdominal preperitoneal inguinal hernia repair (TAPP)
• Signed Informed consent to participation
• ASA I-III
• BMI ≤35 kg/m2
• Inguinoscrotal hernia (hernia passing through the entrance to the scrotum)
• Previously diagnosed mental disorders
• Patients receiving psychotropic drugs and drugs affecting adrenal cortex function (estrogens and systemic glucocorticoids)
• Language barrier

You may not qualify if:

• Deviations during the operation/anesthesia that required transfer to the intensive care unit or conversion to open surgery
• Refusal to participate

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Department of faculty surgery №1 Pirogov Russian National Research Medical University

Moscow, 117997, Russia

RECRUITING

Related Publications (12)

• Aasvang EK, Gmaehle E, Hansen JB, Gmaehle B, Forman JL, Schwarz J, Bittner R, Kehlet H. Predictive risk factors for persistent postherniotomy pain. Anesthesiology. 2010 Apr;112(4):957-69. doi: 10.1097/ALN.0b013e3181d31ff8.

  PMID: 20234307 BACKGROUND

• Arora S, Chhabra A, Subramaniam R, Arora MK, Misra MC, Bansal VK. Transversus abdominis plane block for laparoscopic inguinal hernia repair: a randomized trial. J Clin Anesth. 2016 Sep;33:357-64. doi: 10.1016/j.jclinane.2016.04.047. Epub 2016 May 28.

  PMID: 27555193 BACKGROUND

• Chamzin A, Frountzas M, Gkiokas G, Kouskouni E, Xanthos T, Michalopoulos NV. The Effect of Intraoperative Transversus Abdominis Plane Blocking on Postoperative Pain After Laparoscopic Transabdominal Pre-peritoneal (TAPP) Groin Hernia Repair. Front Surg. 2022 Feb 8;9:834050. doi: 10.3389/fsurg.2022.834050. eCollection 2022.

  PMID: 35211504 BACKGROUND

• Gao T, Zhang JJ, Xi FC, Shi JL, Lu Y, Tan SJ, Yu WK. Evaluation of Transversus Abdominis Plane (TAP) Block in Hernia Surgery: A Meta-analysis. Clin J Pain. 2017 Apr;33(4):369-375. doi: 10.1097/AJP.0000000000000412.

  PMID: 27518492 BACKGROUND

• Hosni M, Soulios, JP, Francart, D. Ultrasound transversus abdominis plane (TAP) block versus local infiltration analgesia for acute and chronic postoperative pain control after laparoscopic bilateral hernia repair: a single-center randomized controlled trial. Acta Anaesthesiologica Belgica. 2020; 71(4), 171-174. https://doi.org/10.56126/71.4.2

  BACKGROUND

• Hubbard G, Hubert C, Vudayagiri L, Tullington J, Merino K, Vaidya A, Gemma R. Transversus abdominis plane blocks in laparoscopic inguinal hernia repair: a review. Hernia. 2023 Oct;27(5):1059-1065. doi: 10.1007/s10029-023-02831-x. Epub 2023 Jul 3.

  PMID: 37395916 BACKGROUND

• HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.

  PMID: 29330835 BACKGROUND

• Kim MG, Kim SI, Ok SY, Kim SH, Lee SJ, Park SY, Lee SM, Jung BI. The analgesic effect of ultrasound-guided transverse abdominis plane block after laparoscopic totally extraperitoneal hernia repair. Korean J Anesthesiol. 2012 Sep;63(3):227-32. doi: 10.4097/kjae.2012.63.3.227. Epub 2012 Sep 14.

  PMID: 23060979 BACKGROUND

• Paasch C, Fiebelkorn J, Berndt N, De Santo G, Aljedani N, Ortiz P, Gauger U, Boettge K, Anders S, Full H, Strik MW. The transversus abdominis plane block reduces the cumulative need of analgesic medication following inguinal hernia repair in TAPP technique: a retrospective single center analysis among 838 patients. Hernia. 2020 Dec;24(6):1371-1378. doi: 10.1007/s10029-020-02156-z. Epub 2020 Mar 13.

  PMID: 32170456 BACKGROUND

• Paasch C, Fiebelkorn J, De Santo G, Azarhoush S, Boettge K, Anders S, Gauger U, Strik M. The transversus abdominis plane block may reduce chronic postoperative pain one year after TAPP ingunial hernia repair. Ann Med Surg (Lond). 2020 May 23;55:190-194. doi: 10.1016/j.amsu.2020.04.011. eCollection 2020 Jul.

  PMID: 32518639 BACKGROUND

• Reinpold W. Risk factors of chronic pain after inguinal hernia repair: a systematic review. Innov Surg Sci. 2017 May 12;2(2):61-68. doi: 10.1515/iss-2017-0017. eCollection 2017 Jun.

  PMID: 31579738 BACKGROUND

• Takebayashi K, Matsumura M, Kawai Y, Hoashi T, Katsura N, Fukuda S, Shimizu K, Inada T, Sato M. Efficacy of transversus abdominis plane block and rectus sheath block in laparoscopic inguinal hernia surgery. Int Surg. 2015 Apr;100(4):666-71. doi: 10.9738/INTSURG-D-14-00193.1.

  PMID: 25875548 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Taras Nechay, MD

CONTACT

+79268146829; tnechay@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 9, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)