Abdominal Muscles/UltrasonographyNCT01589796
Medial Versus Traditional Approach to US-guided TAP Blocks for Open Inguinal Hernia Repair
A study testing TAP block in people with Abdominal Muscles/Ultrasonography and Adult, run by Stamford Anesthesiology Services, PC at 2 sites in United States.
Trial summary
Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The investigators hypothesize that doing TAP block closer to the middle of the abdomen would result in improved pain relief due to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures
- What is being tested?
- TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 - 75 years of age undergoing open inguinal hernia repair.
- Ability to read and write English
Who cannot join
- Patients undergoing other concomitant procedure
- Patients with history of diabetes or chronic steroid use
- Patients with chronic or recent (within 1 week prior to procedure) opioid use.
- Patients without the mental capacity to consent for the procedure/study.
- Patients requiring a translator in order to sign the consent for the procedure/study.
- Patients with a history of allergic reactions to local anesthetics
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Tully Health Center
Stamford, Connecticut, 06902
Vlad Frenk, MD, 203-276-7490
Vlad Frenk, MD
- Recruiting
Stamford Hospital
Stamford, Connecticut, 06904
Vlad Frenk, MD
Theresa Bowling, MD
About this study
Official title: Effect of Medial vs Traditional Approach to US-guided Transverse Abdominis Plane (TAP) Blocks on Analgesia After Open Inguinal Hernia Repair
Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The investigators hypothesize that doing TAP block closer to the middle of the abdomen would result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric nerves.
Read the detailed description
This study is a prospective, open, randomized trial. Subjects will be randomized using a computer-generated table of random numbers into 2 groups to receive pre-incisional ipsilateral ultrasound-guided TAP block using classic or medial approach. Group assignments will be sealed in sequentially numbered, opaque envelopes that would be opened by an anesthesiologist performing the block. The research nurse, not involved with patient care after the subject signed written informed consent, will provide postoperative data collection. Study subjects and other anesthesia care providers will also be blinded to group allocation.
All patients will be premedicated with 1-2mg IV midazolam and 50-150 mcg IV fentanyl. In the OR, propofol infusion will be started at 75mcg/kg/hr and titrated for patient comfort. After patient is adequately sedated, ultrasound guided TAP block will be performed in all subjects using a linear 6-15MHz ultrasound probe on a portable ultrasound machine (SonoSite, Bothell, WA). Classic approach group will receive a TAP block as previously described (Hebbard P, 2007). For the medial approach, once the external oblique abdominal, the internal oblique abdominal, and the transversus abdominal muscles were visualized using the ultrasound transducer between the costal margin and the iliac crest at the level of the anterior axillary line (classic approach), the transducer would be moved medially to the point where internal oblique muscle disappears. The injection target area will be within 1 inch lateral to that point.
The place of needle insertion will be prepped with Chlorhexidine gluconate 2% antiseptic solution, and 21G 90-mm StimuQuik needle (Arrow International, Reading, PA) will be used to inject 20ml of Ropivacaine 0.5% in the proper place once it is identified. Each subject will receive local infiltration with 20ml of Lidocaine1% : Bupivacaine 0.25% 1:1 mix prior to the incision by the surgeon as well as 1000 mg of IV acetaminophen and 8 mg IV dexamethasone intraoperatively.
In the postanesthesia care unit (PACU), the patient will be asked to rate their pain at rest upon arrival and at regular intervals on a 0 to 10 numeric rating scale (NRS), where 0 means no pain and 10 is the worst pain imaginable. Hydromorphone 0.5 mg IV will be administered every 5 minutes to maintain an NRS pain score <4 of 10. In cases of postoperative nausea or vomiting, subjects will receive 4mg IV ondansetron, followed by 12.5 mg IV Diphenhydramine if necessary. The Aldrete Recovery Score will be used to transfer the patients from Phase I of recovery, which focuses on providing a transition from a totally anesthetized state to one requiring less intervention. Aldrete Scoring System assesses respiration, oxygen saturation, consciousness, circulation and activity. Each item is scored on a 0 to 2 scale with higher score representing more advanced recovery. Once the score of 9 or higher is reached, the subjects will be transferred to Phase II recovery, which focuses on preparing the patient for dicharge. At discharge, subjects will be instructed to take a combination of oxycodone 5mg and acetaminophen 325mg orally every 4-6 hours for NRS pain score>4 of 10. Postoperative opioid consumption for the 48 hours will be converted to an equivalent dose of oral hydromorphone.
Subjects will be contacted by telephone by a research nurse or one of the investigators not involved in their care, and will be asked about their pain and amount of pain medication they consumed since discharge or since the last phone call respectively. In case of a potential problem, the matter will be referred to a physician.
- Conditions
- Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures, Anesthetics, Local/Administration & Dosage, Ropivacaine/Administration & Dosage, Ropivacaine/Analogs & Derivatives
- Being tested
- TAP block
- Keywords
- anesthesia, regional anesthetic techniques: transversus abdominis plane block, ilioinguinal nerve block, iliohypogastric nerve block, surgery, inguinal herniorrhaphy, pain, postoperative, surgery, inguinal hernia repair
- Medical subject headings
- Hernia, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
injection of 20ml of Ropivacaine 0.5% in the proper place once it is identified
| Study group | Role | What they receive |
|---|---|---|
| classic TAP | Active comparator | classic US-guided TAP block in a space between iliac crest and the costal margin in the region of the anterior axillary line Receives: Procedure: TAP block |
| Medial TAP | Active comparator | US-guided TAP block in a space between iliac crest and the costal margin within 1 inch lateral to transversus abdominis muscle origination Receives: Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption after two above mentioned techniques
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal Muscles/UltrasonographyStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stamford Anesthesiology Services, PC
- Sponsor type
- University, hospital or other
- Collaborators
- I-Flow
- Responsible party
- Principal investigator, Dr. Vlad Frenk, Stamford Anesthesiology Services, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589796
- Sponsor's protocol ID
- 12-0308.03
- Status last verified
- Apr 2012
- First submitted
- 26 Apr 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.
PubMed 21177284Fredrickson MJ, Paine C, Hamill J. Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Paediatr Anaesth. 2010 Nov;20(11):1022-7. doi: 10.1111/j.1460-9592.2010.03432.x.
PubMed 20964768Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
PubMed 18020088Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.
PubMed 22012289Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x.
PubMed 15025612
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medial vs Traditional Approach to US-guided Transverse Abdominis Plane (TAP) Blocks on Analgesia After Open Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01589796
- Acronym / sponsor ID
- 12-0308.03
- Conditions
- Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures, Anesthetics, Local/Administration & Dosage, Ropivacaine/Administration & Dosage, Ropivacaine/Analogs & Derivatives
- Keywords
- anesthesia, regional anesthetic techniques: transversus abdominis plane block, ilioinguinal nerve block, iliohypogastric nerve block, surgery, inguinal herniorrhaphy, pain, postoperative, surgery, inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stamford Anesthesiology Services, PCUniversity, hospital or other
- Collaborators
- I-Flow
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (estimated)
- First posted
- 2 May 2012 (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.
Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The investigators hypothesize that doing TAP block closer to the middle of the abdomen would result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric nerves.
Detailed description
This study is a prospective, open, randomized trial. Subjects will be randomized using a computer-generated table of random numbers into 2 groups to receive pre-incisional ipsilateral ultrasound-guided TAP block using classic or medial approach. Group assignments will be sealed in sequentially numbered, opaque envelopes that would be opened by an anesthesiologist performing the block. The research nurse, not involved with patient care after the subject signed written informed consent, will provide postoperative data collection. Study subjects and other anesthesia care providers will also be blinded to group allocation.
All patients will be premedicated with 1-2mg IV midazolam and 50-150 mcg IV fentanyl. In the OR, propofol infusion will be started at 75mcg/kg/hr and titrated for patient comfort. After patient is adequately sedated, ultrasound guided TAP block will be performed in all subjects using a linear 6-15MHz ultrasound probe on a portable ultrasound machine (SonoSite, Bothell, WA). Classic approach group will receive a TAP block as previously described (Hebbard P, 2007). For the medial approach, once the external oblique abdominal, the internal oblique abdominal, and the transversus abdominal muscles were visualized using the ultrasound transducer between the costal margin and the iliac crest at the level of the anterior axillary line (classic approach), the transducer would be moved medially to the point where internal oblique muscle disappears. The injection target area will be within 1 inch lateral to that point.
The place of needle insertion will be prepped with Chlorhexidine gluconate 2% antiseptic solution, and 21G 90-mm StimuQuik needle (Arrow International, Reading, PA) will be used to inject 20ml of Ropivacaine 0.5% in the proper place once it is identified. Each subject will receive local infiltration with 20ml of Lidocaine1% : Bupivacaine 0.25% 1:1 mix prior to the incision by the surgeon as well as 1000 mg of IV acetaminophen and 8 mg IV dexamethasone intraoperatively.
In the postanesthesia care unit (PACU), the patient will be asked to rate their pain at rest upon arrival and at regular intervals on a 0 to 10 numeric rating scale (NRS), where 0 means no pain and 10 is the worst pain imaginable. Hydromorphone 0.5 mg IV will be administered every 5 minutes to maintain an NRS pain score <4 of 10. In cases of postoperative nausea or vomiting, subjects will receive 4mg IV ondansetron, followed by 12.5 mg IV Diphenhydramine if necessary. The Aldrete Recovery Score will be used to transfer the patients from Phase I of recovery, which focuses on providing a transition from a totally anesthetized state to one requiring less intervention. Aldrete Scoring System assesses respiration, oxygen saturation, consciousness, circulation and activity. Each item is scored on a 0 to 2 scale with higher score representing more advanced recovery. Once the score of 9 or higher is reached, the subjects will be transferred to Phase II recovery, which focuses on preparing the patient for dicharge. At discharge, subjects will be instructed to take a combination of oxycodone 5mg and acetaminophen 325mg orally every 4-6 hours for NRS pain score>4 of 10. Postoperative opioid consumption for the 48 hours will be converted to an equivalent dose of oral hydromorphone.
Subjects will be contacted by telephone by a research nurse or one of the investigators not involved in their care, and will be asked about their pain and amount of pain medication they consumed since discharge or since the last phone call respectively. In case of a potential problem, the matter will be referred to a physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic TAP | Active comparator | Procedure: TAP blockclassic US-guided TAP block in a space between iliac crest and the costal margin in the region of the anterior axillary line |
| Medial TAP | Active comparator | Procedure: TAP blockUS-guided TAP block in a space between iliac crest and the costal margin within 1 inch lateral to transversus abdominis muscle origination |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 - 75 years of age undergoing open inguinal hernia repair.
- Ability to read and write English
Key exclusion criteria (6 listed)
- Patients undergoing other concomitant procedure
- Patients with history of diabetes or chronic steroid use
- Patients with chronic or recent (within 1 week prior to procedure) opioid use.
- Patients without the mental capacity to consent for the procedure/study.
- Patients requiring a translator in order to sign the consent for the procedure/study.
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 blockinjection of 20ml of Ropivacaine 0.5% in the proper place once it is identified | Procedure or surgery | Medial TAP, classic TAP |
Primary outcome
Analgesic consumption after two above mentioned techniques
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
- Background: PubMed 21177284Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.
- Background: PubMed 20964768Fredrickson MJ, Paine C, Hamill J. Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Paediatr Anaesth. 2010 Nov;20(11):1022-7. doi: 10.1111/j.1460-9592.2010.03432.x.
- Background: PubMed 18020088Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
- Background: PubMed 22012289Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.
- Background: PubMed 15025612Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block in people with Abdominal Muscles/Ultrasonography and Adult, run by Stamford Anesthesiology Services, PC at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vlad Frenk, MD (203 276-7490, vfrenk@stmahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption after two above mentioned techniques (time frame: 48 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 NCT01589796, which also lists 5 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 2 May 2012.