Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545409
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPRATS
Brief Summary:
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block SPSIP Block for postoperative pain control reducing opioid analgesic consumption minimizing postoperative respiratory complications and enhancing patient satisfaction measured using the QoR-15 index in patients undergoing robotic thymectomy compared to patients who do not receive the block
Detailed Description:
All patients enrolled in the study will receive the SPSIP Block under ultrasound guidance 15 minutes before entering the operating room The SPSIP Block will be performed by the attending anesthetist investigator 1 who will use a syringe pre-filled with 30 ml of a solution prepared in advance by another investigator investigator 2 According to the randomization scheme the solution in the syringe used for the SPSIP Block will contain either 025 bupivacaine for 50 of the cases SPSIP group or sterile saline solution 09 NaCl for the remaining 50 of the cases control group Postoperatively data collection will be managed by a third investigator investigator 3 Neither the investigator 1 the patient nor the investigator 3 will be informed of the syringes contents ensuring the study is conducted blind
All patients enrolled in the study will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of the surgery during skin closure Additionally upon arrival in the recovery room all patients will be connected to a PCA Patient Controlled Analgesia pump filled with a solution containing opioids Patients who have NPRS scores greater than 4 during postoperative pain reassessments despite PCA use will be given a rescue analgesic dose of 1000 mg of paracetamol which can be repeated after 8 hours up to a maximum of 3000 mg in 24 hours
Postoperative pain intensity will be assessed by investigator 3 at 0 2 6 12 and 24 hours after the end of surgery using the Numeric Pain Rating Scale NPRS Assessments will be conducted both at rest and during coughing Total opioid and rescue analgesic consumption incidence of postoperative complications and length of hospital stay will also be recorded Twenty-four hours after the surgery investigator 3 will administer the Quality of Recovery 15 QoR-15 questionnaire to all patients enrolled in the study The responses will be used by investigator 3 to calculate the QoR-15 Index which summarizes the degree of patient satisfaction
All patients enrolled in the study will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of the surgery during skin closure Additionally upon arrival in the recovery room all patients will be connected to a PCA Patient Controlled Analgesia pump filled with a solution containing opioids Patients who have NPRS scores greater than 4 during postoperative pain reassessments despite PCA use will be given a rescue analgesic dose of 1000 mg of paracetamol which can be repeated after 8 hours up to a maximum of 3000 mg in 24 hours
Postoperative pain intensity will be assessed by investigator 3 at 0 2 6 12 and 24 hours after the end of surgery using the Numeric Pain Rating Scale NPRS Assessments will be conducted both at rest and during coughing Total opioid and rescue analgesic consumption incidence of postoperative complications and length of hospital stay will also be recorded Twenty-four hours after the surgery investigator 3 will administer the Quality of Recovery 15 QoR-15 questionnaire to all patients enrolled in the study The responses will be used by investigator 3 to calculate the QoR-15 Index which summarizes the degree of patient satisfaction
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