Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Emergency Abdominal Surgery With Midline Incision
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Patients Undergoing Emergency Abdominal Surgery With Midline Incision A Randomized Controlled Trial
Status:
NOT_YET_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:
Most of the recommendations regarding pain management in emergency abdominal surgery are extracted from data from elective abdominal surgery However surgery in the emergency settings differs from the elective settings in the extent stress and the pain which is usually present preoperatively therefore it is expected to have different analgesic requirements and different response to pain management interventions in emergency surgery
Abdominal wall blocks are increasingly used in abdominal surgery However data regarding their efficacy in emergency setting are lacking Oblique-subcostal transversus abdominis plane block OS-TAPB is a variation of the subcostal TAPB that could achieve effective analgesia for both upper and lower parts of the abdomen The TAPB characterized by being easy to perform and does not require patient repositioning Erector spinae plane block ESPB is another abdominal wall block that showed good analgesic effect following various elective open abdominal surgeries but the block requires patient repositioning before block performance In elective abdominal surgeries the current evidence slightly supports ESPB over the TAPB We hypothesize that the difference between the two blocks would be more apparent in in emergency surgery due to the type of incision extent of tissue manipulation and severity of pain
Abdominal wall blocks are increasingly used in abdominal surgery However data regarding their efficacy in emergency setting are lacking Oblique-subcostal transversus abdominis plane block OS-TAPB is a variation of the subcostal TAPB that could achieve effective analgesia for both upper and lower parts of the abdomen The TAPB characterized by being easy to perform and does not require patient repositioning Erector spinae plane block ESPB is another abdominal wall block that showed good analgesic effect following various elective open abdominal surgeries but the block requires patient repositioning before block performance In elective abdominal surgeries the current evidence slightly supports ESPB over the TAPB We hypothesize that the difference between the two blocks would be more apparent in in emergency surgery due to the type of incision extent of tissue manipulation and severity of pain
Detailed Description:
Upon arrival to the operating room routine monitors electrocardiogram pulse oximetry and non-invasive blood pressure monitor will be applied intravenous line will be secured and pre-medication drugs will be delivered metoclopramide 10 mg and omeprazole 40 mg
General anesthesia will be induced by 2 mgkg propofol and 1 mcgkg fentanyl After loss of consciousness tracheal intubation by direct laryngoscopy will be facilitated by 1 mgkg succinyl choline Anesthesia will be maintained by 1-12 isoflurane and atracurium will be administered after patient recovery from succinylcholine at a dose of 05 mgKg Atracurium increments of 01 mgkg will be administered every 20 min for maintenance of neuromuscular blockade
After induction of anesthesia patients will receive the block according to the group assignment In both blocks a total of 25 mL of 025 bupivacaine will be administered in each side
The blocks will be performed by an experienced operator who will be informed of the patient group after induction of anesthesia The patient surgeon and data collector will be blinded to the study group
Intraoperative analgesic management Fentanyl boluses of 1 mcgkg will be given in case of inadequate analgesia heart ratemean blood pressure increase by 20 from the baseline in absence of other causes Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist
At the end of the surgery all patients will receive intravenous acetaminophen 1 g before the extubation
Postoperative care All patients will receive regular intravenous acetaminophen 1 g6 hours Pain assessments using NRS will be performed at rest and during cough at 05 1 4 8 12 24 h after leaving the operating room If NRS score is 3 at any time not limited to the time of assessment intravenous titration of 3 mg morphine is given slowly to be repeated after 30 minutes if pain persisted If other opioids are given morphine equivalent dose will be calculated using opioids conversion chart
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs
General anesthesia will be induced by 2 mgkg propofol and 1 mcgkg fentanyl After loss of consciousness tracheal intubation by direct laryngoscopy will be facilitated by 1 mgkg succinyl choline Anesthesia will be maintained by 1-12 isoflurane and atracurium will be administered after patient recovery from succinylcholine at a dose of 05 mgKg Atracurium increments of 01 mgkg will be administered every 20 min for maintenance of neuromuscular blockade
After induction of anesthesia patients will receive the block according to the group assignment In both blocks a total of 25 mL of 025 bupivacaine will be administered in each side
The blocks will be performed by an experienced operator who will be informed of the patient group after induction of anesthesia The patient surgeon and data collector will be blinded to the study group
Intraoperative analgesic management Fentanyl boluses of 1 mcgkg will be given in case of inadequate analgesia heart ratemean blood pressure increase by 20 from the baseline in absence of other causes Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist
At the end of the surgery all patients will receive intravenous acetaminophen 1 g before the extubation
Postoperative care All patients will receive regular intravenous acetaminophen 1 g6 hours Pain assessments using NRS will be performed at rest and during cough at 05 1 4 8 12 24 h after leaving the operating room If NRS score is 3 at any time not limited to the time of assessment intravenous titration of 3 mg morphine is given slowly to be repeated after 30 minutes if pain persisted If other opioids are given morphine equivalent dose will be calculated using opioids conversion chart
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs
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?:
None
Is an FDA AA801 Violation?:
None