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

Primary Purpose

Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP block
Sponsored by
Stamford Anesthesiology Services, PC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Muscles/Ultrasonography focused on measuring anesthesia, regional anesthetic techniques: transversus abdominis plane block, ilioinguinal nerve block, iliohypogastric nerve block, surgery, inguinal herniorrhaphy, pain, postoperative, surgery, inguinal hernia repair

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tully Health CenterRecruiting
  • Stamford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

classic TAP

Medial TAP

Arm Description

classic US-guided TAP block in a space between iliac crest and the costal margin in the region of the anterior axillary line

US-guided TAP block in a space between iliac crest and the costal margin within 1 inch lateral to transversus abdominis muscle origination

Outcomes

Primary Outcome Measures

Analgesic consumption after two above mentioned techniques

Secondary Outcome Measures

Full Information

First Posted
April 26, 2012
Last Updated
April 30, 2012
Sponsor
Stamford Anesthesiology Services, PC
Collaborators
I-Flow
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1. Study Identification

Unique Protocol Identification Number
NCT01589796
Brief Title
Medial Versus Traditional Approach to US-guided TAP Blocks for Open Inguinal Hernia Repair
Official Title
Effect of Medial vs Traditional Approach to US-guided Transverse Abdominis Plane (TAP) Blocks on Analgesia After Open Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stamford Anesthesiology Services, PC
Collaborators
I-Flow

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
anesthesia, regional anesthetic techniques: transversus abdominis plane block, ilioinguinal nerve block, iliohypogastric nerve block, surgery, inguinal herniorrhaphy, pain, postoperative, surgery, inguinal hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
classic TAP
Arm Type
Active Comparator
Arm Description
classic US-guided TAP block in a space between iliac crest and the costal margin in the region of the anterior axillary line
Arm Title
Medial TAP
Arm Type
Active Comparator
Arm Description
US-guided TAP block in a space between iliac crest and the costal margin within 1 inch lateral to transversus abdominis muscle origination
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
injection of 20ml of Ropivacaine 0.5% in the proper place once it is identified
Primary Outcome Measure Information:
Title
Analgesic consumption after two above mentioned techniques
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vlad Frenk, MD
Phone
203 276-7490
Email
vfrenk@stmahealth.org
Facility Information:
Facility Name
Tully Health Center
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vlad Frenk, MD
Phone
203-276-7490
First Name & Middle Initial & Last Name & Degree
Vlad Frenk, MD
First Name & Middle Initial & Last Name & Degree
Theresa Bowling, MD
First Name & Middle Initial & Last Name & Degree
Debbie Bakes, MD
First Name & Middle Initial & Last Name & Degree
Gayle Appleby, MSN, RN
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vlad Frenk, MD
First Name & Middle Initial & Last Name & Degree
Theresa Bowling, MD
First Name & Middle Initial & Last Name & Degree
Debbie Bakes, MD
First Name & Middle Initial & Last Name & Degree
Gayle Appleby, MSN, RN

12. IPD Sharing Statement

Citations:
PubMed Identifier
21177284
Citation
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.
Results Reference
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PubMed Identifier
20964768
Citation
Fredrickson 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.
Results Reference
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PubMed Identifier
18020088
Citation
Hebbard 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.
Results Reference
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PubMed Identifier
22012289
Citation
Santos 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.
Results Reference
background
PubMed Identifier
15025612
Citation
Toivonen 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.
Results Reference
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Medial Versus Traditional Approach to US-guided TAP Blocks for Open Inguinal Hernia Repair

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