Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409156
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-07
Brief Title:
EOIFP Block Versus OSTAP Block for Upper Abdominal Surgery
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Feasibility Pilot Study Assessing the Effects of External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block for Upper Abdominal Surgery A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
The investigators propose a single-center assessor blinded randomized control trial to compare the efficacy of external oblique fascial plane EOIFP block versus Oblique Subcostal Transversus Abdominis Plane OSTAP block for patients undergoing open upper abdominal surgery at Cleveland Clinic Main Campus
Detailed Description:
The investigators propose a single-center assessor blinded randomized control trial to compare the efficacy of external oblique fascial plane EOIFP block versus Oblique Subcostal Transversus Abdominis Plane OSTAP block for patients undergoing open upper abdominal surgery at Cleveland Clinic Main Campus
Participating patients and outcome assessors will be blinded to group assignment The anesthesiologists who perform the blocks will not be blinded to group assignment
American Society of Anesthesiologists ASA physical status 1-3 adults scheduled for elective open upper abdominal surgery with supraumbilical incision with anticipated 3 days postoperative hospitalization at Cleveland Clinic Main Campus will be included in the study Patients will be excluded if they have chronic hepatic or kidney disease Pregnant or breastfeeding participants will not be eligible for this study
Patients will be randomly assigned to 1 EOIFP block or 2 OSTAP block The location of each block will be performed as previously described The procedure will be performed using sterile technique under ultrasound guidance Once the target is visualized a 20-gauge 4-inch echogenic needle will be advanced in-plane to the fascial plane 5 ml of 09 normal saline will be injected through the needle to open the fascial plane and then a single dose 10 ml of liposomal bupivacaine mixed with 20 mL of bupivacaine 025 will be injected on each side General anesthesia will be induced at the attending anesthesiologists discretion and maintained with sevoflurane or isoflurane Intraoperative analgesic use will be up to the anesthesiologist preference Postoperatively patients will be given IV Dilaudid or fentanyl or morphine equivalent for pain relief as needed as well as oral Tylenol 1000mg every 8 hours unless contraindicated Toradol can be given as part of multimodal analgesia if cleared by the surgical team Clinicians will adjust analgesic management as necessary in an effort to keep verbal response pain scores 4 Nurses will adjust analgesic management as necessary in an effort to keep verbal response pain scores 4
Other anti-inflammatory drugs will not be used intraoperatively or for the initial 48 postoperative hours A single dose of dexamethasone 4-8 mg will be permitted for PONV prophylaxis for patients with Apfel risk score of 2 or more and inhaled steroids will be permitted as necessary to treat reactive airway disease Other opioid sparing medications like gabapentin pregabalin ketamine or lidocaine patch will also not be permitted through the initial 48 postoperative hours
Clinical evaluators for the outcomes will be blinded to study aim and Pharmacy personnel not involved in evaluations will prepare the study drugs Patients will be continuously monitored and recorded with a wireless monitor starting after extubation in the operating room Clinicians including nurses will be blinded to monitoring and will be required to perform their standard of care management after surgery
Patients will be allowed to receive prophylactic anti-emetic first choice ondansetron intraoperatively based on the risk assessment for nausea and vomiting Postoperative anti-emetics for symptomatic treatment will also be allowed
Participating patients and outcome assessors will be blinded to group assignment The anesthesiologists who perform the blocks will not be blinded to group assignment
American Society of Anesthesiologists ASA physical status 1-3 adults scheduled for elective open upper abdominal surgery with supraumbilical incision with anticipated 3 days postoperative hospitalization at Cleveland Clinic Main Campus will be included in the study Patients will be excluded if they have chronic hepatic or kidney disease Pregnant or breastfeeding participants will not be eligible for this study
Patients will be randomly assigned to 1 EOIFP block or 2 OSTAP block The location of each block will be performed as previously described The procedure will be performed using sterile technique under ultrasound guidance Once the target is visualized a 20-gauge 4-inch echogenic needle will be advanced in-plane to the fascial plane 5 ml of 09 normal saline will be injected through the needle to open the fascial plane and then a single dose 10 ml of liposomal bupivacaine mixed with 20 mL of bupivacaine 025 will be injected on each side General anesthesia will be induced at the attending anesthesiologists discretion and maintained with sevoflurane or isoflurane Intraoperative analgesic use will be up to the anesthesiologist preference Postoperatively patients will be given IV Dilaudid or fentanyl or morphine equivalent for pain relief as needed as well as oral Tylenol 1000mg every 8 hours unless contraindicated Toradol can be given as part of multimodal analgesia if cleared by the surgical team Clinicians will adjust analgesic management as necessary in an effort to keep verbal response pain scores 4 Nurses will adjust analgesic management as necessary in an effort to keep verbal response pain scores 4
Other anti-inflammatory drugs will not be used intraoperatively or for the initial 48 postoperative hours A single dose of dexamethasone 4-8 mg will be permitted for PONV prophylaxis for patients with Apfel risk score of 2 or more and inhaled steroids will be permitted as necessary to treat reactive airway disease Other opioid sparing medications like gabapentin pregabalin ketamine or lidocaine patch will also not be permitted through the initial 48 postoperative hours
Clinical evaluators for the outcomes will be blinded to study aim and Pharmacy personnel not involved in evaluations will prepare the study drugs Patients will be continuously monitored and recorded with a wireless monitor starting after extubation in the operating room Clinicians including nurses will be blinded to monitoring and will be required to perform their standard of care management after surgery
Patients will be allowed to receive prophylactic anti-emetic first choice ondansetron intraoperatively based on the risk assessment for nausea and vomiting Postoperative anti-emetics for symptomatic treatment will also be allowed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None