Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386978
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-15
Brief Title:
Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
Examination of the Postoperative Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section Surgeries Performed Under Spinal Anesthesia
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study was designed as a prospective randomized observational clinical trial
A total of 90 adult women were included in the study performed elective cesarean section
After excluding patients the care of 90 was included and 3 of these amounts were reserved
TAP Block Group n30Group 1 Spinal Anesthesia TAP block TFP Block group n30Group 2 Spinal Anesthesia TFP block Control group n30Group 3 Spinal Anesthesia No block
A total of 90 adult women were included in the study performed elective cesarean section
After excluding patients the care of 90 was included and 3 of these amounts were reserved
TAP Block Group n30Group 1 Spinal Anesthesia TAP block TFP Block group n30Group 2 Spinal Anesthesia TFP block Control group n30Group 3 Spinal Anesthesia No block
Detailed Description:
This study was designed as a prospective randomized observational clinical trial Erciyes University Clinical Research Ethics Board 2024209
All participants in the study were adults and their information was confirmed in writing Preoperative anesthesia assessment was made by an anesthetic injection cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025 ASA score anesthesia method age weight height TAP block group Group I or TFP block group Group II Control group Group III
Duration of spinal anesthesia time of first analgesic request total analgesic consumption for 24-48 hours VAS score additional analgesics patient satisfaction possible postoperative bleeding vomiting heat retention and other interruptions were recorded in the patients
Those who were allergic to local anesthetics steroid treatment areas ASA III ASA IV and ASA V patients under the age of 18 preeclampsia eclampsia placenta percreta and accreta complications and emergency hospitals were excluded from the study After excluding patients the care of 90 was included and 3 of these amounts were reserved
TAP Block Group n30Group 1 Spinal Anesthesia TAP block TFP Block group n30Group 2 Spinal Anesthesia TFP block Control group n30Group 3 Spinal Anesthesia No block At the end of the surgery TAP Transverse Abdominis Plane Block Block or TFP Transversalis Fascia Plane Block block was performed under aseptic conditions under ultrasonography guidance
TAP Transverse Abdominis Plane Block Block for Group 1 patients and TFP Transversalis Fascia Plane Block block for Group 2 patients on both sides after negative aspiration with 20 ml 025 bupivacaine Marcaine Astra-Zeneca Turkey under ultrasonography guidance It was done under aseptic conditions
Patients who did not accept both blocks were included in Group 3 Control group
All patients were trained on visual analog score VAS by the anesthesia assistant during the preoperative evaluation VAS used for pain assessment a 10 cm long horizontal line was used
From 0 no pain to 10 most severe pain
PCA morphine administration to all patients The hourly limit was set as 4 mg and the repeat limit was set as 10 minutes If the 1 mg IV morphine bolus dose was not sufficient it was planned to repeat it after 10 minutes and if it was still not sufficient paracetamol and diclofenac were planned to be administered
All participants in the study were adults and their information was confirmed in writing Preoperative anesthesia assessment was made by an anesthetic injection cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025 ASA score anesthesia method age weight height TAP block group Group I or TFP block group Group II Control group Group III
Duration of spinal anesthesia time of first analgesic request total analgesic consumption for 24-48 hours VAS score additional analgesics patient satisfaction possible postoperative bleeding vomiting heat retention and other interruptions were recorded in the patients
Those who were allergic to local anesthetics steroid treatment areas ASA III ASA IV and ASA V patients under the age of 18 preeclampsia eclampsia placenta percreta and accreta complications and emergency hospitals were excluded from the study After excluding patients the care of 90 was included and 3 of these amounts were reserved
TAP Block Group n30Group 1 Spinal Anesthesia TAP block TFP Block group n30Group 2 Spinal Anesthesia TFP block Control group n30Group 3 Spinal Anesthesia No block At the end of the surgery TAP Transverse Abdominis Plane Block Block or TFP Transversalis Fascia Plane Block block was performed under aseptic conditions under ultrasonography guidance
TAP Transverse Abdominis Plane Block Block for Group 1 patients and TFP Transversalis Fascia Plane Block block for Group 2 patients on both sides after negative aspiration with 20 ml 025 bupivacaine Marcaine Astra-Zeneca Turkey under ultrasonography guidance It was done under aseptic conditions
Patients who did not accept both blocks were included in Group 3 Control group
All patients were trained on visual analog score VAS by the anesthesia assistant during the preoperative evaluation VAS used for pain assessment a 10 cm long horizontal line was used
From 0 no pain to 10 most severe pain
PCA morphine administration to all patients The hourly limit was set as 4 mg and the repeat limit was set as 10 minutes If the 1 mg IV morphine bolus dose was not sufficient it was planned to repeat it after 10 minutes and if it was still not sufficient paracetamol and diclofenac were planned to be administered
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