Inguinal HerniaTAP-dexNCT04403711
Dexmedetomidine in TAP Block for Inguinal Hernia Repair
A study testing local anesthetic and dexmedetomidine in people with Inguinal Hernia and Analgesia, run by Aretaieion University Hospital at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia, Analgesia, Pain, Acute
- What is being tested?
- local anesthetic and dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia repair with a mesh
- open hernia repair
- elective surgery
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair
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
Read the 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
- Being tested
- local anesthetic and dexmedetomidine, local anesthetic and placebo
- Keywords
- transversus abdominis plane block, dexmedetomidine
- Medical subject headings
- Hernia, Inguinal, Agnosia, Acute Pain, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anesthetic and dexmedetomidineOther
Also called medication used in regional anesthetic technique
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 placeboOther
Also called medication used in regional anesthetic technique
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
| Study group | Role | What they receive |
|---|---|---|
| local anesthetic and dexmedetomidine | Active comparator | ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine Receives: Other: local anesthetic and dexmedetomidine |
| local anesthetic and placebo | Placebo comparator | ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline Receives: Other: local anesthetic and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 3 hours after surgery
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"
Measured: 6 hours after surgery
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"
Measured: 24 hours after surgery
Secondary outcomes (1)
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
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Apr 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403711
- Sponsor's protocol ID
- TAP-dexmedetomidine
- Acronym
- TAP-dex
- Status last verified
- Jul 2025
- First submitted
- 21 May 2020
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11141218Alfieri 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.
PubMed 21365287Petersen 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.
PubMed 20175754McDonnell 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.
PubMed 17179269Mikkelsen 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.
PubMed 15281521Goudarzi 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.
PubMed 31552872Theodoraki 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.
PubMed 30769214Chen 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.
PubMed 30532583Ramya 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.
PubMed 29662278
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04403711
- Acronym / sponsor ID
- TAP-dex / TAP-dexmedetomidine
- Conditions
- Inguinal Hernia, Analgesia, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Keywords
- transversus abdominis plane block, dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anesthetic and dexmedetomidine | Active comparator | Other: local anesthetic and dexmedetomidineultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine |
| local anesthetic and placebo | Placebo comparator | Other: local anesthetic and placeboultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia repair with a mesh
- open hernia repair
- elective surgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anesthetic and dexmedetomidineAlso: medication used in regional anesthetic techniquein patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine | Other | local anesthetic and dexmedetomidine |
| local anesthetic and placeboAlso: medication used in regional anesthetic techniquein patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline | Other | local anesthetic and placebo |
Primary outcome
pain score 3 hours postoperatively
Time frame: 3 hours after surgery
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
Time frame: 6 hours after surgery
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
Time frame: 24 hours after surgery
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"
1 secondary outcome
incidence of chronic pain
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 11141218Bay-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.
- Background: PubMed 21365287Alfieri 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.
- Background: PubMed 20175754Petersen 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.
- Background: PubMed 17179269McDonnell 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.
- Background: PubMed 15281521Mikkelsen 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.
- Background: PubMed 31552872Goudarzi 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.
- Background: PubMed 30769214Theodoraki 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.
- Background: PubMed 30532583Chen 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.
- Background: PubMed 29662278Ramya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anesthetic and dexmedetomidine in people with Inguinal Hernia and Analgesia, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score 3 hours postoperatively (time frame: 3 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403711, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.