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Dexmedetomidine in TAP Block for Inguinal Hernia Repair (TAP-dex)

Primary Purpose

Inguinal Hernia, Analgesia, Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
local anesthetic and dexmedetomidine
local anesthetic and placebo
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring transversus abdominis plane block, dexmedetomidine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aretaieion University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

local anesthetic and dexmedetomidine

local anesthetic and placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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"
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"
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"

Secondary Outcome Measures

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

Full Information

First Posted
May 21, 2020
Last Updated
July 10, 2022
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04403711
Brief Title
Dexmedetomidine in TAP Block for Inguinal Hernia Repair
Acronym
TAP-dex
Official Title
The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Analgesia, Pain, Acute, Pain, Chronic, Pain, Neuropathic
Keywords
transversus abdominis plane block, dexmedetomidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local anesthetic and dexmedetomidine
Arm Type
Active Comparator
Arm Description
ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine
Arm Title
local anesthetic and placebo
Arm Type
Placebo Comparator
Arm Description
ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline
Intervention Type
Other
Intervention Name(s)
local anesthetic and dexmedetomidine
Other Intervention Name(s)
medication used in regional anesthetic technique
Intervention Description
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
Intervention Name(s)
local anesthetic and placebo
Other Intervention Name(s)
medication used in regional anesthetic technique
Intervention Description
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
Primary Outcome Measure Information:
Title
pain score 3 hours postoperatively
Description
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"
Time Frame
3 hours after surgery
Title
pain score 6 hours postoperatively
Description
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"
Time Frame
6 hours after surgery
Title
pain score 24 hours postoperatively
Description
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"
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
incidence of chronic pain
Description
occurrence of chronic pain at the site of the operation, with the use of the NRS, at rest and during movement
Time Frame
6 months after surgery
Other Pre-specified Outcome Measures:
Title
morphine consumption
Description
morphine consumption through patient-controlled analgesia device for 24 hours postoperatively
Time Frame
24 hours postoperatively
Title
satisfaction from postoperative analgesia
Description
satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
Time Frame
24 hours postoperatively
Title
transversus abdominis plane-related complications
Description
transversus abdominis plane-related complications at the site of the local anesthetic injection
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aretaieion University Hospital
City
Athens
State/Province
Αττική
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ioannis Koutalas, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11141218
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. doi: 10.1097/00000658-200101000-00001.
Results Reference
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PubMed Identifier
21365287
Citation
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.
Results Reference
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PubMed Identifier
20175754
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.
Results Reference
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PubMed Identifier
17179269
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. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
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PubMed Identifier
15281521
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
30769214
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.
Results Reference
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PubMed Identifier
30532583
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.
Results Reference
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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.
Results Reference
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Dexmedetomidine in TAP Block for Inguinal Hernia Repair

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