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Medial Versus Traditional Approach to US-guided TAP Blocks for Open Inguinal Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Stamford Anesthesiology Services, PC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
Dr. Vlad Frenk, Stamford Anesthesiology Services, PC
ClinicalTrials.gov Identifier:
NCT01589796
First received: April 26, 2012
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Abdominal Muscles/Ultrasonography
Adult
Ambulatory Surgical Procedures
Anesthetics, Local/Administration & Dosage
Ropivacaine/Administration & Dosage
Ropivacaine/Analogs & Derivatives
Hernia, Inguinal/Surgery
Humans
Nerve Block/Methods
Pain Measurement/Methods
Pain, Postoperative/Prevention & Control
Ultrasonography, Interventional
Procedure: TAP block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Medial vs Traditional Approach to US-guided Transverse Abdominis Plane (TAP) Blocks on Analgesia After Open Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Stamford Anesthesiology Services, PC:

Primary Outcome Measures:
  • Analgesic consumption after two above mentioned techniques [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: classic TAP
classic US-guided TAP block in a space between iliac crest and the costal margin in the region of the anterior axillary line
Procedure: TAP block
injection of 20ml of Ropivacaine 0.5% in the proper place once it is identified
Active Comparator: Medial TAP
US-guided TAP block in a space between iliac crest and the costal margin within 1 inch lateral to transversus abdominis muscle origination
Procedure: TAP block
injection of 20ml of Ropivacaine 0.5% in the proper place once it is identified

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 - 75 years of age undergoing open inguinal hernia repair.
  • Ability to read and write English

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589796

Contacts
Contact: Vlad Frenk, MD 203 276-7490 vfrenk@stmahealth.org

Locations
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
Principal Investigator: Vlad Frenk, MD         
Sub-Investigator: Theresa Bowling, MD         
Sub-Investigator: Debbie Bakes, MD         
Sub-Investigator: Gayle Appleby, MSN, RN         
Tully Health Center Recruiting
Stamford, Connecticut, United States, 06902
Contact: Vlad Frenk, MD    203-276-7490      
Principal Investigator: Vlad Frenk, MD         
Sub-Investigator: Theresa Bowling, MD         
Sub-Investigator: Debbie Bakes, MD         
Sub-Investigator: Gayle Appleby, MSN, RN         
Sponsors and Collaborators
Stamford Anesthesiology Services, PC
I-Flow
  More Information

Publications:
Responsible Party: Dr. Vlad Frenk, attending anesthesiologist, Stamford Anesthesiology Services, PC
ClinicalTrials.gov Identifier: NCT01589796     History of Changes
Other Study ID Numbers: 12-0308.03
Study First Received: April 26, 2012
Last Updated: April 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stamford Anesthesiology Services, PC:
anesthesia
regional anesthetic techniques: transversus abdominis plane block, ilioinguinal nerve block, iliohypogastric nerve block
surgery, inguinal herniorrhaphy
pain, postoperative
surgery, inguinal hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pain, Postoperative
Hernia, Abdominal
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014