Pain, PostoperativeNCT02375100
Transversus Abdominis Plane Block Versus Ilioinguinal Nerve Block for Pain Management in Inguinal Herniorraphy
A study testing Spinal Anesthesia, Transversus Abdominis Plane Block and Ilioinguinal Nerve Block in people with Pain, Postoperative, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve block for postoperative pain in patients undergoing inguinal herniorraphy with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Spinal Anesthesia, Transversus Abdominis Plane Block and Ilioinguinal Nerve Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years old
- having ASA (American Society of Anesthesiologists) 1 or 2 physical status score preoperatively
- not having a neuromuscular disease
- scheduled for elective single sided inguinal herniorraphy operation
Who cannot join
- being under 18 years of age
- patient refusal
- having a neuromuscular disease or sensorial neurological deficit covering similar area of effect with peripheral nerve block interventions or the surgical site
- having ASA 3 or 4 physical status score preoperatively
- having one of the contraindications to spinal anesthesia and/or to peripheral nerve blocks as listed by NYSORA (New York School of Regional Anesthesia)
- having emergency surgery or scheduled for bilateral inguinal herniorraphy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir, İzmir, 35170
About this study
Official title: Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia
This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve block for postoperative pain in patients undergoing inguinal herniorraphy with spinal anesthesia. One-third of the patients will receive standard postoperative pain regimen(control group), one-third will receive a transversus abdominis plane block (with ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with ultrasound guidance) in addition to standard postoperative pain regimen. This study is a Randomized prospective open-label controlled study.
- Conditions
- Pain, Postoperative
- Being tested
- Spinal Anesthesia, Transversus Abdominis Plane Block, Ilioinguinal Nerve Block, Bupivacaine %0.5 (hyperbaric), Bupivacaine %0.25 (isobaric)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
Also called Spinal Block
All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
Transversus Abdominis Plane BlockProcedure or surgery
Also called TAP block
Analgesic intervention which will be performed only to Transversus Abdominis Plane Block arm. It requires 20ml of %0.25 bupivacaine administration through a 22 G. x 4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel from midaxillary line between costal margin and anterior superior iliac spine with ultrasound guidance
Ilioinguinal Nerve BlockProcedure or surgery
Also called IIN Block
Analgesic intervention which will be performed only to Ilioinguinal Nerve Block arm. It requires 10ml of %0.25 bupivacaine administration through a 22 G. x 3-1/8 in. (80 mm) Insulated Echogenic Needle with 30° Bevel between umbilicus and iliac crest where the nerve is detected with ultrasound guidance
Bupivacaine %0.5 (hyperbaric)Drug
Also called Heavy bupivacaine
Bupivacaine %0.25 (isobaric)Drug
Also called Plain bupivacaine
25G Quincke needleDevice
Echogenic Needle with 30° bevelDevice
AcetaminophenDrug
Also called Analgesics
Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
TramadolDrug
Also called Analgesics
Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal bupivacaine&analgesics | Active comparator | Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period. Receives: Procedure: Spinal Anesthesia; Drug: Bupivacaine %0.5 (hyperbaric); Device: 25G Quincke needle; Drug: Acetaminophen; Drug: Tramadol |
| TAP Block with bupivacaine | Experimental | In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated. Receives: Procedure: Spinal Anesthesia; Procedure: Transversus Abdominis Plane Block; Drug: Bupivacaine %0.5 (hyperbaric); Drug: Bupivacaine %0.25 (isobaric); Device: 25G Quincke needle; Device: Echogenic Needle with 30° bevel; Drug: Acetaminophen; Drug: Tramadol |
| IlNB with bupivacaine | Experimental | In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated. Receives: Procedure: Spinal Anesthesia; Procedure: Ilioinguinal Nerve Block; Drug: Bupivacaine %0.5 (hyperbaric); Drug: Bupivacaine %0.25 (isobaric); Device: 25G Quincke needle; Device: Echogenic Needle with 30° bevel; Drug: Acetaminophen; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: Baseline
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: 2nd hour after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: 4th hour after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: 6th hour after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: 1st day after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: 2nd day after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Measured: 1st month after surgery
Secondary outcomes (15)
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: Baseline
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: 2nd hour after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: 4th hour after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: 6th hour after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: 1st day after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: 2nd day after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Measured: 1st month after surgery
First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)
The time when the patients experience pain perception after surgery for the first time
Measured: whenever in 48 hours after surgery
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: Baseline
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: 2nd hour after surgery
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: 4th hour after surgery
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: 6th hour after surgery
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: 1st day after surgery
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: 2nd day after surgery
Additional analgesic requirements
Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)
Measured: 1st month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Onur Okur, MD,Resident, Principal investigator, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375100
- Sponsor's protocol ID
- IzmirBoyaka
- Status last verified
- Oct 2015
- First submitted
- 19 Feb 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02375100
- Acronym / sponsor ID
- IzmirBoyaka
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Mar 2015 (estimated)
- 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 compares efficacy of transversus abdominis plane block and ilioinguinal nerve block for postoperative pain in patients undergoing inguinal herniorraphy with spinal anesthesia. One-third of the patients will receive standard postoperative pain regimen(control group), one-third will receive a transversus abdominis plane block (with ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with ultrasound guidance) in addition to standard postoperative pain regimen. This study is a Randomized prospective open-label controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrathecal bupivacaine&analgesics | Active comparator | Procedure: Spinal Anesthesia, Drug: Bupivacaine %0.5 (hyperbaric), Device: 25G Quincke needle, Drug: Acetaminophen, Drug: TramadolPatients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period. |
| TAP Block with bupivacaine | Experimental | Procedure: Spinal Anesthesia, Procedure: Transversus Abdominis Plane Block, Drug: Bupivacaine %0.5 (hyperbaric), Drug: Bupivacaine %0.25 (isobaric), Device: 25G Quincke needle, Device: Echogenic Needle with 30° bevel, Drug: Acetaminophen, Drug: TramadolIn addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated. |
| IlNB with bupivacaine | Experimental | Procedure: Spinal Anesthesia, Procedure: Ilioinguinal Nerve Block, Drug: Bupivacaine %0.5 (hyperbaric), Drug: Bupivacaine %0.25 (isobaric), Device: 25G Quincke needle, Device: Echogenic Needle with 30° bevel, Drug: Acetaminophen, Drug: TramadolIn addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over 18 years old
- having ASA (American Society of Anesthesiologists) 1 or 2 physical status score preoperatively
- not having a neuromuscular disease
- scheduled for elective single sided inguinal herniorraphy operation
Key exclusion criteria (6 listed)
- being under 18 years of age
- patient refusal
- having a neuromuscular disease or sensorial neurological deficit covering similar area of effect with peripheral nerve block interventions or the surgical site
- having ASA 3 or 4 physical status score preoperatively
- having one of the contraindications to spinal anesthesia and/or to peripheral nerve blocks as listed by NYSORA (New York School of Regional Anesthesia)
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 |
|---|---|---|
| Spinal AnesthesiaAlso: Spinal BlockAll patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade | Procedure or surgery | IlNB with bupivacaine, Intrathecal bupivacaine&analgesics, TAP Block with bupivacaine |
| Transversus Abdominis Plane BlockAlso: TAP blockAnalgesic intervention which will be performed only to Transversus Abdominis Plane Block arm. It requires 20ml of %0.25 bupivacaine administration through a 22 G. x 4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel from midaxillary line between costal margin and anterior superior iliac spine with ultrasound guidance | Procedure or surgery | TAP Block with bupivacaine |
| Ilioinguinal Nerve BlockAlso: IIN BlockAnalgesic intervention which will be performed only to Ilioinguinal Nerve Block arm. It requires 10ml of %0.25 bupivacaine administration through a 22 G. x 3-1/8 in. (80 mm) Insulated Echogenic Needle with 30° Bevel between umbilicus and iliac crest where the nerve is detected with ultrasound guidance | Procedure or surgery | IlNB with bupivacaine |
| Bupivacaine %0.5 (hyperbaric)Also: Heavy bupivacaine | Drug | IlNB with bupivacaine, Intrathecal bupivacaine&analgesics, TAP Block with bupivacaine |
| Bupivacaine %0.25 (isobaric)Also: Plain bupivacaine | Drug | IlNB with bupivacaine, TAP Block with bupivacaine |
| 25G Quincke needle | Device | IlNB with bupivacaine, Intrathecal bupivacaine&analgesics, TAP Block with bupivacaine |
| Echogenic Needle with 30° bevel | Device | IlNB with bupivacaine, TAP Block with bupivacaine |
| AcetaminophenAlso: AnalgesicsAnalgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely | Drug | IlNB with bupivacaine, Intrathecal bupivacaine&analgesics, TAP Block with bupivacaine |
| TramadolAlso: AnalgesicsPatients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain) | Drug | IlNB with bupivacaine, Intrathecal bupivacaine&analgesics, TAP Block with bupivacaine |
Primary outcome
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: Baseline
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: 2nd hour after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: 4th hour after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: 6th hour after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: 1st day after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: 2nd day after surgery
Pain Assessment with Verbal Descriptor Scale (VDS)
Time frame: 1st month after surgery
15 secondary outcomes
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: Baseline
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: 2nd hour after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: 4th hour after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: 6th hour after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: 1st day after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: 2nd day after surgery
Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))
Time frame: 1st month after surgery
First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)
Time frame: whenever in 48 hours after surgery
Additional analgesic requirements
Time frame: Baseline
Additional analgesic requirements
Time frame: 2nd hour after surgery
Additional analgesic requirements
Time frame: 4th hour after surgery
Additional analgesic requirements
Time frame: 6th hour after surgery
Additional analgesic requirements
Time frame: 1st day after surgery
Additional analgesic requirements
Time frame: 2nd day after surgery
Additional analgesic requirements
Time frame: 1st month 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 28 Oct 2015.
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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.
Onur Okur, MD,Resident principal investigator
Izmir Bozyaka 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 Spinal Anesthesia, Transversus Abdominis Plane Block and Ilioinguinal Nerve Block in people with Pain, Postoperative, run by Bozyaka 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 4 inclusion and 6 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 28 Oct 2015. 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?
Pain Assessment with Verbal Descriptor Scale (VDS) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.