Inguinal HerniaAnalgesiaNCT04227912
Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
A study testing Transversus abdominis plane block, Local anesthetic infiltration and Intravenous dexketoprofen in people with Inguinal Hernia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Transversus abdominis plane block, Local anesthetic infiltration and Intravenous dexketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2019to 1 Oct 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who aged 18-75 years
- American Society of Anesthesiologist (ASA) I-III
- Subject undergoing unilateral or bilateral inguinal hernia repair
Who cannot join
- Subject under 18 and over 75 years of age
- ASA IV
- History of allergy to agents
- Analgesic drug use in the last 48 hours
- Morbid obese (BMI> 35)
- Confusion
Show all 12Show fewer
- Coagulopathy
- Local infection at the injection site
- Subject with heart, lung, hematologic, metabolic and endocrine disease
- Subject who did not want to be included in the study
- Subject who refused the spinal anesthesia
- Subject who failed the spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gazi Yaşargil Training and Research Hospital
Diyarbakır, Eyalet/Yerleşke, 21070
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Preemptive Ultrasound-guided Transversus Abdominis Plane Block, Ultrasound-guided Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.
Read the detailed description
Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.
- Conditions
- Inguinal Hernia
- Being tested
- Transversus abdominis plane block, Local anesthetic infiltration, Intravenous dexketoprofen
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockOther
Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.
Local anesthetic infiltrationOther
Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.
Intravenous dexketoprofenOther
Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.
| Study group | Role | What they receive |
|---|---|---|
| Group TAP | Active comparator | Ultrasound-guided TAP Block Receives: Other: Transversus abdominis plane block |
| Group Local | Active comparator | Ultrasound-guided Local Infiltration Receives: Other: Local anesthetic infiltration |
| Group Dexketoprofen | Active comparator | Intravenous Dexketoprofen Receives: Other: Intravenous dexketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative rescue tramadol consumption
The mean tramadol consumption in the first 24 post-operative hours
Measured: 24 hours
Secondary outcomes (2)
Analgesic efficacy
Postoperative visual analog scale score recorded 0-10 (0 = no pain, 10 = severe pain) at 30. min, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively
Measured: 24 hours
Postoperative nausea-vomiting
Postoperative nausea-vomiting was evaluated with a 3-point system (0: no nausea and vomiting, 1: nausea, but no vomiting, 2: nausea with or without nausea) 24 hours postoperatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start11 Feb 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fikret Salık, Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227912
- Sponsor's protocol ID
- SBUGaziYasargilTRH
- Acronym
- Analgesia
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
PubMed 21928388Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.
PubMed 23549122
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Preemptive Ultrasound-guided Transversus Abdominis Plane Block, Ultrasound-guided Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04227912
- Acronym / sponsor ID
- Analgesia / SBUGaziYasargilTRH
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 14 Jan 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 study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.
Detailed description
Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group TAP | Active comparator | Other: Transversus abdominis plane blockUltrasound-guided TAP Block |
| Group Local | Active comparator | Other: Local anesthetic infiltrationUltrasound-guided Local Infiltration |
| Group Dexketoprofen | Active comparator | Other: Intravenous dexketoprofenIntravenous Dexketoprofen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject who aged 18-75 years
- American Society of Anesthesiologist (ASA) I-III
- Subject undergoing unilateral or bilateral inguinal hernia repair
Key exclusion criteria (12 listed)
- Subject under 18 and over 75 years of age
- ASA IV
- History of allergy to agents
- Analgesic drug use in the last 48 hours
- Morbid obese (BMI> 35)
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 |
|---|---|---|
| Transversus abdominis plane blockBefore surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients. | Other | Group TAP |
| Local anesthetic infiltrationBefore surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients. | Other | Group Local |
| Intravenous dexketoprofenBefore surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients. | Other | Group Dexketoprofen |
Primary outcome
Postoperative rescue tramadol consumption
Time frame: 24 hours
The mean tramadol consumption in the first 24 post-operative hours
2 secondary outcomes
Analgesic efficacy
Time frame: 24 hours
Postoperative nausea-vomiting
Time frame: 24 hours
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 14 Jan 2020.
- Results publication: PubMed 21928388Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
- Results publication: PubMed 23549122Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.
- European Journal of AnaesthesiologyLink provided by the sponsor.
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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.
Fikret Salık principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 Transversus abdominis plane block, Local anesthetic infiltration and Intravenous dexketoprofen in people with Inguinal Hernia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 12 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 14 Jan 2020. 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 Turkey (Türkiye). 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. 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?
Postoperative rescue tramadol consumption (time frame: 24 hours). 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 NCT04227912, which also lists 2 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 14 Jan 2020.