Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423677
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-16
Brief Title:
Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane SPSIP Block in Shoulder Arthroscopies
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Organization:
Kanuni Sultan Suleyman Training and Research Hospital
Study Overview
Official Title:
Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane SPSIP Block in Shoulder Arthroscopies A Randomized Controlled Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery After ensuring aseptic conditions the block site will be wiped three times with 10 povidone-iodine the linear ultrasound probe will be covered in a sterile manner While performing the block the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially After imaging the 2nd and 3rd ribs on the medial side of the scapular spine the block needle will be advanced under ultrasound guidance onto the 3rd rib After contacting the rib with the needle it will be retracted by 1mm and the block site will be confirmed by injecting sterile 09 NaCl Subsequently patients will be administered 30ml of 025 bupivacaine in a controlled manner
Before awakening both the block group and the non-block group will be administered 1g of paracetamol and 1mgkg of tramadol intravenously In the postoperative period these patients will be provided with multimodal analgesia including intravenous patient-controlled analgesia PCA with 4mgml Tramadol HCl in 100ml NaCl There will be no basal infusion with bolus doses of 20mg and a lockout period of 20 minutes and a total dose limitation of 200mg over 4 hours Patients will be visited at 0 1 6 12 and 24 hours and they will be asked to draw their visual analog scale VAS score on a paper scale The amount of opioid used in the PCA and the need for rescue analgesia Arveles 50mg intravenously will be assessed Patients will routinely receive 4x1g paracetamol in the postoperative period
Before awakening both the block group and the non-block group will be administered 1g of paracetamol and 1mgkg of tramadol intravenously In the postoperative period these patients will be provided with multimodal analgesia including intravenous patient-controlled analgesia PCA with 4mgml Tramadol HCl in 100ml NaCl There will be no basal infusion with bolus doses of 20mg and a lockout period of 20 minutes and a total dose limitation of 200mg over 4 hours Patients will be visited at 0 1 6 12 and 24 hours and they will be asked to draw their visual analog scale VAS score on a paper scale The amount of opioid used in the PCA and the need for rescue analgesia Arveles 50mg intravenously will be assessed Patients will routinely receive 4x1g paracetamol in the postoperative period
Detailed Description:
Patient Positioning and Preparation
Patient Positioning
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery This positioning facilitates access to the block site and ensures patient comfort
Aseptic Technique
The block site will be prepared by wiping it three times with 10 povidone-iodine to ensure asepsis
The linear ultrasound probe will be covered in a sterile manner to prevent contamination during the procedure
Ultrasound-Guided Block Procedure
Probe Placement and Rib Identification
The Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side
The probe will be slid medially to identify the 2nd and 3rd ribs on the medial side of the scapular spine Accurate identification of these ribs is crucial for proper needle placement
Needle Insertion and Block Site Confirmation
A block needle will be advanced under ultrasound guidance onto the 3rd rib The ultrasound guidance ensures precise needle placement minimizing the risk of complications
Once the needle contacts the rib it will be retracted by 1mm This slight retraction helps position the needle tip correctly for optimal drug delivery
The block site will be confirmed by injecting sterile 09 NaCl The spread of saline under ultrasound visualization confirms the correct location
Anesthetic Administration
Following confirmation of the block site 30ml of 025 bupivacaine will be administered in a controlled manner The controlled administration ensures a steady and effective distribution of the anesthetic agent
Perioperative Analgesia Management
Pre-Awakening Medication
Before awakening from surgery both the block group and the non-block group will receive
1g of paracetamol intravenously
1mgkg of tramadol intravenously
Postoperative Analgesia
Postoperative analgesia will be managed using a multimodal approach including
Intravenous patient-controlled analgesia PCA with 4mgml Tramadol HCl in 100ml NaCl
The PCA will be set with no basal infusion allowing patients to self-administer bolus doses of 20mg with a lockout period of 20 minutes
The total dose limitation will be set at 200mg over 4 hours to prevent overdose and manage pain effectively
Postoperative Assessment and Follow-Up
VAS Score Monitoring
Patients will be visited at the following time intervals postoperatively 0 1 6 12 and 24 hours
During each visit patients will be asked to record their pain levels using the visual analog scale VAS on a paper scale This subjective measure provides valuable insight into the patients pain experience
Opioid Consumption and Rescue Analgesia
The amount of opioid used via PCA will be recorded to evaluate opioid consumption
The need for rescue analgesia will be assessed and documented If required patients will receive 50mg of Arveles intravenously
Routine Postoperative Medication
All patients will receive routine postoperative medication including 4x1g paracetamol to maintain baseline analgesia and reduce overall opioid requirements
Randomization Process
Randomization Protocol
Patients scheduled for surgery will be randomly assigned to either the block group or the non-block group to ensure unbiased allocation and comparability between groups
Randomization will be performed using a computer-generated random number sequence ensuring that each patient has an equal chance of being allocated to either group
Allocation concealment will be maintained by using opaque sealed envelopes containing the group assignments These envelopes will only be opened after patient consent and immediately before the block procedure
Blinding
The study will implement a single-blind design where the patients will be unaware of their group assignment to minimize bias in self-reported outcomes
The healthcare providers responsible for postoperative care and outcome assessment will also be blinded to the group allocation to ensure objective evaluation of the study endpoints
Patient Positioning
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery This positioning facilitates access to the block site and ensures patient comfort
Aseptic Technique
The block site will be prepared by wiping it three times with 10 povidone-iodine to ensure asepsis
The linear ultrasound probe will be covered in a sterile manner to prevent contamination during the procedure
Ultrasound-Guided Block Procedure
Probe Placement and Rib Identification
The Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side
The probe will be slid medially to identify the 2nd and 3rd ribs on the medial side of the scapular spine Accurate identification of these ribs is crucial for proper needle placement
Needle Insertion and Block Site Confirmation
A block needle will be advanced under ultrasound guidance onto the 3rd rib The ultrasound guidance ensures precise needle placement minimizing the risk of complications
Once the needle contacts the rib it will be retracted by 1mm This slight retraction helps position the needle tip correctly for optimal drug delivery
The block site will be confirmed by injecting sterile 09 NaCl The spread of saline under ultrasound visualization confirms the correct location
Anesthetic Administration
Following confirmation of the block site 30ml of 025 bupivacaine will be administered in a controlled manner The controlled administration ensures a steady and effective distribution of the anesthetic agent
Perioperative Analgesia Management
Pre-Awakening Medication
Before awakening from surgery both the block group and the non-block group will receive
1g of paracetamol intravenously
1mgkg of tramadol intravenously
Postoperative Analgesia
Postoperative analgesia will be managed using a multimodal approach including
Intravenous patient-controlled analgesia PCA with 4mgml Tramadol HCl in 100ml NaCl
The PCA will be set with no basal infusion allowing patients to self-administer bolus doses of 20mg with a lockout period of 20 minutes
The total dose limitation will be set at 200mg over 4 hours to prevent overdose and manage pain effectively
Postoperative Assessment and Follow-Up
VAS Score Monitoring
Patients will be visited at the following time intervals postoperatively 0 1 6 12 and 24 hours
During each visit patients will be asked to record their pain levels using the visual analog scale VAS on a paper scale This subjective measure provides valuable insight into the patients pain experience
Opioid Consumption and Rescue Analgesia
The amount of opioid used via PCA will be recorded to evaluate opioid consumption
The need for rescue analgesia will be assessed and documented If required patients will receive 50mg of Arveles intravenously
Routine Postoperative Medication
All patients will receive routine postoperative medication including 4x1g paracetamol to maintain baseline analgesia and reduce overall opioid requirements
Randomization Process
Randomization Protocol
Patients scheduled for surgery will be randomly assigned to either the block group or the non-block group to ensure unbiased allocation and comparability between groups
Randomization will be performed using a computer-generated random number sequence ensuring that each patient has an equal chance of being allocated to either group
Allocation concealment will be maintained by using opaque sealed envelopes containing the group assignments These envelopes will only be opened after patient consent and immediately before the block procedure
Blinding
The study will implement a single-blind design where the patients will be unaware of their group assignment to minimize bias in self-reported outcomes
The healthcare providers responsible for postoperative care and outcome assessment will also be blinded to the group allocation to ensure objective evaluation of the study endpoints
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