Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01589796
Status:
UNKNOWN
Last Update Posted:
2012-05-02
First Post:
2012-04-26
Brief Title:
Medial Versus Traditional Approach to US-guided TAP Blocks for Open Inguinal Hernia Repair
Sponsor:
Stamford Anesthesiology Services PC
Organization:
Stamford Anesthesiology Services PC
Study Overview
Official Title:
Effect of Medial vs Traditional Approach to US-guided Transverse Abdominis Plane TAP Blocks on Analgesia After Open Inguinal Hernia Repair
Status:
UNKNOWN
Status Verified Date:
2012-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinaliliohypogastric 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 ilioinguinaliliohypogastric 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 75mcgkghr 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 05 in the proper place once it is identified Each subject will receive local infiltration with 20ml of Lidocaine1 Bupivacaine 025 11 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 05 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 125 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 score4 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
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 75mcgkghr 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 05 in the proper place once it is identified Each subject will receive local infiltration with 20ml of Lidocaine1 Bupivacaine 025 11 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 05 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 125 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 score4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None