Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655298
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Evaluation of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Pain ReliefFollowing Laparoscopic Nephrectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Pain ReliefFollowing Laparoscopic Nephrectomy
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
The aim of this study is to assess the efficacy of Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing laparoscopic nephrectomy
Detailed Description:
The study will be a prospective randomized single-blind study Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block
The study will be conducted on 56 patients 28 patients in each group
Group Q 28 patients Quadratus lumborum block group patients will receive general anesthesia initially then bilateral QLB type III anterior subcoastal approach with a volume of 30 mL of bupivacaine 025 for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed 25 mgkg
Group E 28 patients Erector spinae plane block patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 025 for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed 25 mgkg
Data Collection
Baseline
1 Patient demographic data
2 Hemodynamics pulse- heart rate- mean blood pressure baseline before induction of anesthesia
Intraoperative
1 Hemodynamics pulse- heart rate- mean blood pressure
They will be monitored and recorded 5 minutes after induction of anesthesia then every 30 min till end of the surgery
2 Total analgesic consumption needed to reach target Entropy measurement 40-60
3 The anesthetic time it is the time that starts when the anesthesia provider begins to administer the IV anesthetics and ends with tracheal extubation and surgical time starts with skin incision and ends with last suture and putting dressings on
4 The time taken to perform the block
5 Number of patients needed ephedrine andor atropine and total amount of their administration will be recorded
6 Recovery time time since anesthetics discontinuation till reaching score 9 of Alderetes criteria
Postoperative
1 Time of first call for rescue analgesia
2 Number of patients requested analgesia postoperative
3 Visual analogue scale VAS on admission to post-anesthetic care unit PACU every 30 minutes for next 2 hours every 2 hours for next 6 hours and every 4 hours for the rest of the 24 hours postoperatively
Discharge from PACU will be according to Postanesthesia Discharge Scoring System14Appendix3
4 Hemodynamics pulse- heart rate- mean blood pressure
They will be assessed as follow
On admission to post-anesthetic care unit PACU then every 30 minutes at 30 60 90 120 minutes then every 2 hours for next 6 hours then every 6 hours for remaining 24 hours
5 Vomiting nausea and starting time of intestinal movements
6 Duration of the block from the injection time of local anesthetic till complete return of sensation
The study will be conducted on 56 patients 28 patients in each group
Group Q 28 patients Quadratus lumborum block group patients will receive general anesthesia initially then bilateral QLB type III anterior subcoastal approach with a volume of 30 mL of bupivacaine 025 for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed 25 mgkg
Group E 28 patients Erector spinae plane block patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 025 for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed 25 mgkg
Data Collection
Baseline
1 Patient demographic data
2 Hemodynamics pulse- heart rate- mean blood pressure baseline before induction of anesthesia
Intraoperative
1 Hemodynamics pulse- heart rate- mean blood pressure
They will be monitored and recorded 5 minutes after induction of anesthesia then every 30 min till end of the surgery
2 Total analgesic consumption needed to reach target Entropy measurement 40-60
3 The anesthetic time it is the time that starts when the anesthesia provider begins to administer the IV anesthetics and ends with tracheal extubation and surgical time starts with skin incision and ends with last suture and putting dressings on
4 The time taken to perform the block
5 Number of patients needed ephedrine andor atropine and total amount of their administration will be recorded
6 Recovery time time since anesthetics discontinuation till reaching score 9 of Alderetes criteria
Postoperative
1 Time of first call for rescue analgesia
2 Number of patients requested analgesia postoperative
3 Visual analogue scale VAS on admission to post-anesthetic care unit PACU every 30 minutes for next 2 hours every 2 hours for next 6 hours and every 4 hours for the rest of the 24 hours postoperatively
Discharge from PACU will be according to Postanesthesia Discharge Scoring System14Appendix3
4 Hemodynamics pulse- heart rate- mean blood pressure
They will be assessed as follow
On admission to post-anesthetic care unit PACU then every 30 minutes at 30 60 90 120 minutes then every 2 hours for next 6 hours then every 6 hours for remaining 24 hours
5 Vomiting nausea and starting time of intestinal movements
6 Duration of the block from the injection time of local anesthetic till complete return of sensation
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