Dexmedetomidine in TAP Block for Inguinal Hernia Repair

NCT ID: NCT04403711

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-12-31

Brief Summary

This prospective double-blind randomized study will aim at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal hernia repair under general anesthesia

Detailed Description

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide, especially in the day-case setting. It can be accompanied by moderate to severe postoperative pain, which can delay return to normal daily activities or lead to the development of chronic pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43% with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block is an effective regional anesthetic technique to reduce postoperative pain intensity, time to first rescue anesthetic administration and opioid demand after upper and lower abdominal surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing unilateral elective inguinal hernia repair with the Lichtenstein technique under general anesthesia.

Conditions

Inguinal Hernia; Analgesia; Pain, Acute; Pain, Chronic; Pain, Neuropathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

local anesthetic and dexmedetomidine

ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine

Group Type: ACTIVE_COMPARATOR

local anesthetic and dexmedetomidine

Intervention Type: OTHER

in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine

local anesthetic and placebo

ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline

Group Type: PLACEBO_COMPARATOR

local anesthetic and placebo

Intervention Type: OTHER

in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline

Interventions

local anesthetic and dexmedetomidine

in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine

Intervention Type: OTHER

local anesthetic and placebo

in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline

Intervention Type: OTHER

Other Intervention Names

medication used in regional anesthetic technique; medication used in regional anesthetic technique

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia repair with a mesh
• open hernia repair
• elective surgery

Exclusion Criteria

• inability to consent to the study due to language barriers or cognitive dysfunction -
• bilateral inguinal hernia repair,
• body mass index over 40 kg m-2,
• skin infection at the puncture site
• contraindication to paracetamol or non-steroidal anti-inflammatory drug (NSAIDs) administration
• known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
• coagulation abnormalities
• history of gastroesophageal reflux and preoperative use of opioids or NSAIDs for chronic pain conditions
• reoperation of recurrent inguinal hernia after previous mesh repair

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aretaieion University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Kassiani Theodoraki

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kassiani Theodoraki, PhD, DESA

Role: PRINCIPAL_INVESTIGATOR

Aretaieion University Hospital

Locations

Aretaieion University Hospital

Athens, Attica, Greece

Countries

Greece

References

Bay-Nielsen M, Perkins FM, Kehlet H; Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001 Jan;233(1):1-7. doi: 10.1097/00000658-200101000-00001.

Reference Type: BACKGROUND

PMID: 11141218 (View on PubMed)

Alfieri S, Amid PK, Campanelli G, Izard G, Kehlet H, Wijsmuller AR, Di Miceli D, Doglietto GB. International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia. 2011 Jun;15(3):239-49. doi: 10.1007/s10029-011-0798-9. Epub 2011 Mar 2.

Reference Type: BACKGROUND

PMID: 21365287 (View on PubMed)

Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.

Reference Type: BACKGROUND

PMID: 20175754 (View on PubMed)

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

Reference Type: BACKGROUND

PMID: 17179269 (View on PubMed)

Mikkelsen T, Werner MU, Lassen B, Kehlet H. Pain and sensory dysfunction 6 to 12 months after inguinal herniotomy. Anesth Analg. 2004 Jul;99(1):146-151. doi: 10.1213/01.ANE.0000115147.14626.C5.

Reference Type: BACKGROUND

PMID: 15281521 (View on PubMed)

Goudarzi TH, Kamali A, Yazdi B, Broujerdi GN. Addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% increasing the duration of postoperative analgesia in the lower abdominal pain surgery among children: A double-blinded randomized clinical study. Med Gas Res. 2019 Jul-Sep;9(3):110-114. doi: 10.4103/2045-9912.266984.

Reference Type: BACKGROUND

PMID: 31552872 (View on PubMed)

Theodoraki K, Papacharalampous P, Tsaroucha A, Vezakis A, Argyra E. The effect of transversus abdominis plane block on acute and chronic pain after inguinal hernia repair. A randomized controlled trial. Int J Surg. 2019 Mar;63:63-70. doi: 10.1016/j.ijsu.2019.02.007. Epub 2019 Feb 12.

Reference Type: BACKGROUND

PMID: 30769214 (View on PubMed)

Chen Q, Liu X, Zhong X, Yang B. Addition of dexmedetomidine or fentanyl to ropivacaine for transversus abdominis plane block: evaluation of effect on postoperative pain and quality of recovery in gynecological surgery. J Pain Res. 2018 Nov 16;11:2897-2903. doi: 10.2147/JPR.S178516. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30532583 (View on PubMed)

Ramya Parameswari A, Udayakumar P. Comparison of Efficacy of Bupivacaine with Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Elective Caesarean Section. J Obstet Gynaecol India. 2018 Apr;68(2):98-103. doi: 10.1007/s13224-017-0990-7. Epub 2017 Apr 26.

Reference Type: BACKGROUND

PMID: 29662278 (View on PubMed)

Other Identifiers

TAP-dexmedetomidine

Identifier Type: -

Identifier Source: org_study_id