Dexmedetomidine in TAP Block for Inguinal Hernia Repair

Analgesia Clinical Trial

— TAP-dex  

Official title:

The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403711
• Other study ID #: TAP-dexmedetomidine
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Neuralgia
• Pain, Acute
• Pain, Chronic
• Pain, Neuropathic

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Greece	Aretaieion University Hospital	Athens	?tt???

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	morphine consumption	morphine consumption through patient-controlled analgesia device for 24 hours postoperatively	24 hours postoperatively
Other	satisfaction from postoperative analgesia	satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction	24 hours postoperatively
Other	transversus abdominis plane-related complications	transversus abdominis plane-related complications at the site of the local anesthetic injection	48 hours postoperatively
Primary	pain score 3 hours postoperatively	pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	3 hours after surgery
Primary	pain score 6 hours postoperatively	pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	6 hours after surgery
Primary	pain score 24 hours postoperatively	pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	24 hours after surgery
Secondary	incidence of chronic pain	occurrence of chronic pain at the site of the operation, with the use of the NRS, at rest and during movement	6 months after surgery