PainTAPNCT01429480
Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy
A study testing Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block and Preoperative Ultrasound Guided Posterior TAP Block in people with Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain
- What is being tested?
- Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block and Preoperative Ultrasound Guided Posterior TAP Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Aug 2013
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair
Who cannot join
- Inability to consent to the study
- BMI more than 40
- Skin infection near injection site
- Chronic hepatic or renal failure
- Peripheral neuropathy
- Proven opioid dependency
Show all 12Show fewer
- Coagulopathy
- Thrombocytopenia
- Dementia
- Lack of orientation
- Impossibility to understand VAS
- Patients suffering from chronic pain
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Anatoly Stav, MD, 972-4-630-4529
Anatoly Stav, MD
About this study
Official title: Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy
TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. The researchers wish to investigate whether the TAP block is as effective as the ilioinguinal/iliohypogastric nerve block?
- Conditions
- Pain
- Being tested
- Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block, Preoperative Ultrasound Guided Posterior TAP Block, Patient controlled analgesia
- Keywords
- Analgesia, postoperative
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric BlockProcedure or surgery
Preoperative Ultrasound Guided Posterior TAP BlockProcedure or surgery
Patient controlled analgesiaDrug
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Active comparator | Not described Receives: Procedure: Preoperative Ultrasound Guided Posterior TAP Block |
| II/IH Block | Active comparator | Not described Receives: Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block |
| Control Group | Active comparator | Not described Receives: Drug: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Intensity of pain in rest and during movement at the operation day and 2 days postoperaive.
Measured: 2 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429480
- Sponsor's protocol ID
- 0065-11-HYMC
- Acronym
- TAP
- Status last verified
- Sep 2011
- First submitted
- 4 Sep 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stav A, Reytman L, Stav MY, Troitsa A, Kirshon M, Alfici R, Dudkiewicz M, Sternberg A. Transversus Abdominis Plane Versus Ilioinguinal and Iliohypogastric Nerve Blocks for Analgesia Following Open Inguinal Herniorrhaphy. Rambam Maimonides Med J. 2016 Jul 28;7(3):e0021. doi: 10.5041/RMMJ.10248.
PubMed 27487311
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT01429480
- Acronym / sponsor ID
- TAP / 0065-11-HYMC
- Conditions
- Pain
- Keywords
- Analgesia, postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 7 Sep 2011 (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.
TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. The researchers wish to investigate whether the TAP block is as effective as the ilioinguinal/iliohypogastric nerve block?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Active comparator | Procedure: Preoperative Ultrasound Guided Posterior TAP Block |
| II/IH Block | Active comparator | Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block |
| Control Group | Active comparator | Drug: Patient controlled analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair
Key exclusion criteria (12 listed)
- Inability to consent to the study
- BMI more than 40
- Skin infection near injection site
- Chronic hepatic or renal failure
- Peripheral neuropathy
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 |
|---|---|---|
| Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block | Procedure or surgery | II/IH Block |
| Preoperative Ultrasound Guided Posterior TAP Block | Procedure or surgery | TAP Block |
| Patient controlled analgesia | Drug | Control Group |
Primary outcome
postoperative pain
Time frame: 2 days postoperatively
Intensity of pain in rest and during movement at the operation day and 2 days postoperaive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Derived from this study: PubMed 27487311Stav A, Reytman L, Stav MY, Troitsa A, Kirshon M, Alfici R, Dudkiewicz M, Sternberg A. Transversus Abdominis Plane Versus Ilioinguinal and Iliohypogastric Nerve Blocks for Analgesia Following Open Inguinal Herniorrhaphy. Rambam Maimonides Med J. 2016 Jul 28;7(3):e0021. doi: 10.5041/RMMJ.10248.
- Related InfoLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block and Preoperative Ultrasound Guided Posterior TAP Block in people with Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 2 days postoperatively). 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 NCT01429480, which also lists 1 linked publication.
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 7 Sep 2011.