Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900116
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2021-04-26
Brief Title:
Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Comparison of Local Anesthetic Dose in PENG Pericapsular Nerve Group Block Performed for Postoperative Analgesia in Total Hip Replacement Operations
Status:
COMPLETED
Status Verified Date:
2022-02
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:
The investigators research was designed as a single-center prospective randomized double-blind study The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included Patients or persons who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained Patients who do not give consent will not be included in the study
Patients will be given US guided PENG blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included
PENG block will be done for postoperative analgesia After the PENG block a single dose of spinal anesthesia will be applied as a regional anesthesia method in a sitting position using the appropriate spinal needle as is routinely applied in the investigators clinic After the block is completed the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed Oxygen will be given to the patients with a face mask at 4 lt min throughout the operation ECG saturation invasive noninvasive blood pressure monitoring of the patients will be done Measurements made at 5-minute intervals will be recorded
In the investigators clinic the use of PENG block and PCA patient controlled analgesia device with intravenous morphine for postoperative analgesia is routinely performed In this study four randomized groups will be formed together with the control group
The local anesthetic solution given by the supervisor whose doses of local anesthetic are predetermined the investigators and participants do not know the dosage with a total volume of 20 cc will be used Local anesthetic agent will not be applied to the control group As mentioned above spinal anesthesia will be performed after PENG block and the operation will be started
Pain score and total morphine consumption will be determined by visual pain scoring VAS at the postoperative 0 6 12 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups As in routine practice when VAS4 after each interrogation morphine 005 mgkg iv will be administered as additional analgesia and the maximum will be increased to 10 mg Pain management will continue when VAS 4
Patients will be given US guided PENG blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included
PENG block will be done for postoperative analgesia After the PENG block a single dose of spinal anesthesia will be applied as a regional anesthesia method in a sitting position using the appropriate spinal needle as is routinely applied in the investigators clinic After the block is completed the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed Oxygen will be given to the patients with a face mask at 4 lt min throughout the operation ECG saturation invasive noninvasive blood pressure monitoring of the patients will be done Measurements made at 5-minute intervals will be recorded
In the investigators clinic the use of PENG block and PCA patient controlled analgesia device with intravenous morphine for postoperative analgesia is routinely performed In this study four randomized groups will be formed together with the control group
The local anesthetic solution given by the supervisor whose doses of local anesthetic are predetermined the investigators and participants do not know the dosage with a total volume of 20 cc will be used Local anesthetic agent will not be applied to the control group As mentioned above spinal anesthesia will be performed after PENG block and the operation will be started
Pain score and total morphine consumption will be determined by visual pain scoring VAS at the postoperative 0 6 12 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups As in routine practice when VAS4 after each interrogation morphine 005 mgkg iv will be administered as additional analgesia and the maximum will be increased to 10 mg Pain management will continue when VAS 4
Detailed Description:
The investigators research was designed as a single-center prospective randomized double-blind study After the approval of the Ethics Committee the study will start and is aimed to be completed in 12 months
The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included Patients or persons who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained Patients who do not give consent will not be included in the study
Patients will be evaluated preoperative before surgery a detailed history will be taken and physical examination will be carried out Medical and surgical resume information will be obtained Patients Vas scores will be recorded before the operation Patients will be taken to the operating room after premedication
ECG pulse oximeter blood pressure monitoring will be performed in the operating room Patients will be given US guided PENG blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included
PENG block will be done for postoperative analgesia After the PENG block a single dose of spinal anesthesia will be applied as a regional anesthesia method in a sitting position using the appropriate spinal needle as is routinely applied in the investigators clinic After the block is completed the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed Oxygen will be given to the patients with a face mask at 4 lt min throughout the operation
ECG saturation invasive noninvasive blood pressure monitoring of the patients will be done Measurements made at 5-minute intervals will be recorded
In the investigators clinic the use of PENG block and PCA patient controlled analgesia device with intravenous morphine for postoperative analgesia is routinely performed In this study four randomized groups will be formed together with the control group Computer-generated random numbers will be used for simple randomization of patients
The local anesthetic solution given by the supervisor whose doses of local anesthetic are predetermined the investigators and participants do not know the dosage with a total volume of 20 cc will be used Local anesthetic agent will not be applied to the control group As mentioned above spinal anesthesia will be performed after PENG block and the operation will be started
Pain score and total morphine consumption will be determined by visual pain scoring VAS at the postoperative 0 6 12 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups As in routine practice when VAS4 after each interrogation morphine 005 mgkg iv will be administered as additional analgesia and the maximum will be increased to 10 mg Pain management will continue when VAS 4
Patients are followed up in the service for 48 hours postoperatively in routine practice In the postoperative period patients will be evaluated in terms of additional nausea and vomiting first mobilization time hospitalization time amount of morphine consumed and additional analgesic need onset time of narcotic analgesic need preoperative and postoperative in the first month Depression-BECK Score quadriceps weakness postop patient satisfaction and surgical satisfaction During the procedure complications such as failed block nerve damage vascular injury intravenous injection of local anesthetic local anesthetic toxicity and allergic reactions will be recorded
Before the study it was determined that at least 84 patients should be collected in the power analysis performed with the help of similar literature data After collecting the demographic data and morphine consumption data of the patients the data will be transferred to the statistical program called SPSS and statistical analysis will be madeThe investigators study does not contain any modifications other than the investigators daily routine practices
The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included Patients or persons who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained Patients who do not give consent will not be included in the study
Patients will be evaluated preoperative before surgery a detailed history will be taken and physical examination will be carried out Medical and surgical resume information will be obtained Patients Vas scores will be recorded before the operation Patients will be taken to the operating room after premedication
ECG pulse oximeter blood pressure monitoring will be performed in the operating room Patients will be given US guided PENG blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included
PENG block will be done for postoperative analgesia After the PENG block a single dose of spinal anesthesia will be applied as a regional anesthesia method in a sitting position using the appropriate spinal needle as is routinely applied in the investigators clinic After the block is completed the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed Oxygen will be given to the patients with a face mask at 4 lt min throughout the operation
ECG saturation invasive noninvasive blood pressure monitoring of the patients will be done Measurements made at 5-minute intervals will be recorded
In the investigators clinic the use of PENG block and PCA patient controlled analgesia device with intravenous morphine for postoperative analgesia is routinely performed In this study four randomized groups will be formed together with the control group Computer-generated random numbers will be used for simple randomization of patients
The local anesthetic solution given by the supervisor whose doses of local anesthetic are predetermined the investigators and participants do not know the dosage with a total volume of 20 cc will be used Local anesthetic agent will not be applied to the control group As mentioned above spinal anesthesia will be performed after PENG block and the operation will be started
Pain score and total morphine consumption will be determined by visual pain scoring VAS at the postoperative 0 6 12 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups As in routine practice when VAS4 after each interrogation morphine 005 mgkg iv will be administered as additional analgesia and the maximum will be increased to 10 mg Pain management will continue when VAS 4
Patients are followed up in the service for 48 hours postoperatively in routine practice In the postoperative period patients will be evaluated in terms of additional nausea and vomiting first mobilization time hospitalization time amount of morphine consumed and additional analgesic need onset time of narcotic analgesic need preoperative and postoperative in the first month Depression-BECK Score quadriceps weakness postop patient satisfaction and surgical satisfaction During the procedure complications such as failed block nerve damage vascular injury intravenous injection of local anesthetic local anesthetic toxicity and allergic reactions will be recorded
Before the study it was determined that at least 84 patients should be collected in the power analysis performed with the help of similar literature data After collecting the demographic data and morphine consumption data of the patients the data will be transferred to the statistical program called SPSS and statistical analysis will be madeThe investigators study does not contain any modifications other than the investigators daily routine practices
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