HydroceleTAPNCT01698268
Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery
A study testing TAP block and Local Infiltration in people with Hydrocele and Inguinal Hernia, run by Kaveh Aslani, MD at 1 site in United States.
Trial summary
Study measures the difference in pain after hernia \&/or hydrocele repair based on site of local anesthesia injection. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Hydrocele, Inguinal Hernia
- What is being tested?
- TAP block and Local Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2-8 years of age
- Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak
- American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)
Who cannot join
- History of allergy to study medications
- Enrollment in concurrent research study
- Pregnant patients*
- Students/trainees/staff*
- Mentally disabled/cognitively impaired*
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair
Study measures the difference in pain after hernia \&/or hydrocele repair based on site of local anesthesia injection.
Read the detailed description
This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.
- Conditions
- Hydrocele, Inguinal Hernia
- Being tested
- TAP block, Local Infiltration
- Medical subject headings
- Testicular Hydrocele, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
Local InfiltrationProcedure or surgery
Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| TAP Group | Experimental | Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. Receives: Procedure: TAP block |
| Local Infiltration Group | Active comparator | Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Receives: Procedure: Local Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.
Measured: Admission into PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HydroceleStudies 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
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaveh Aslani, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaveh Aslani, MD, Corewell Health East
- Investigators
- Kaveh Aslani, MD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698268
- Sponsor's protocol ID
- 2011-213
- Acronym
- TAP
- Status last verified
- Jul 2017
- First submitted
- 14 Aug 2012
- Last updated
- 24 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair
- ClinicalTrials.gov ID
- NCT01698268
- Acronym / sponsor ID
- TAP / 2011-213
- Conditions
- Hydrocele, Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaveh Aslani, MDUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study measures the difference in pain after hernia \&/or hydrocele repair based on site of local anesthesia injection.
Detailed description
This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Group | Experimental | Procedure: TAP blockEnrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. |
| Local Infiltration Group | Active comparator | Procedure: Local InfiltrationEnrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 2-8 years of age
- Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak
- American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)
Key exclusion criteria (5 listed)
- History of allergy to study medications
- Enrollment in concurrent research study
- Pregnant patients*
- Students/trainees/staff*
- Mentally disabled/cognitively impaired*
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 |
|---|---|---|
| TAP blockTAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist. | Procedure or surgery | TAP Group |
| Local InfiltrationLocal infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. | Procedure or surgery | Local Infiltration Group |
Primary outcome
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
Time frame: Admission into PACU
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kaveh Aslani, MD principal investigator
Beaumont Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block and Local Infiltration in people with Hydrocele and Inguinal Hernia, run by Kaveh Aslani, MD at 1 site in United States.
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 5 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 24 Aug 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) (time frame: Admission into PACU). 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 24 Aug 2017.