Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations

Study Overview
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Brief Summary
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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 VAS>4 after each interrogation, morphine 0.05 mg/kg 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
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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 VAS>4 after each interrogation, morphine 0.05 mg/kg 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 made.The investigators study does not contain any modifications other than the investigators daily routine practices.

Official Title
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Comparison of Local Anesthetic Dose in PENG (Pericapsular Nerve Group) Block Performed for Postoperative Analgesia in Total Hip Replacement Operations

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine HCl 0.5 % in 20 ML Injection
* Drug: Bupivacaine HCl 0.25 % in 20 ML Injection
* Drug: Bupivacaine HCl 0.125 % in 20 ML Injection
* Drug: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for total hip replacement surgery under regional anesthesia ASA(American Society of Anesthesiology) 1-3 Receiving consent that accept regional analgesia Exclusion Criteria: Refusal of regional anesthesia Infection on the local anesthetic application area Infection in the central nervous system Coagulopathy Increased intracranial pressure (Brain tumors) Known allergy against local anesthetics Anatomical difficulties

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle. | Drug: Bupivacaine HCl 0.5 % in 20 ML Injection<br>* In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.<br>* Other names: Marcaine;|
| Active Comparator: Group 2<br>In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle. | Drug: Bupivacaine HCl 0.25 % in 20 ML Injection<br>* In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.<br>* Other names: Marcaine;|
| Active Comparator: Group 3<br>In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle. | Drug: Bupivacaine HCl 0.125 % in 20 ML Injection<br>* In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.<br>* Other names: Marcaine;|
| Placebo Comparator: Group 4<br>In this group, US guided PENG block will be performed with 20 ml saline solution (%0.9 NaCl) using a 22 gauge 10 mm block needle. | Drug: NaCl 0.9%<br>* In this group, US guided PENG block will be performed with 20 ml %0.9 NaCl solution using a 22 gauge 10 mm block needle (Control Group).<br>* Other names: Saline Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (0-10) pain scores for patients | The VAS (Visual Analog Scale, 0 mm ''no pain'', to 100 mm, ''the worst pain possible'') | Up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid (mg) consumption | Opioid (mg) consumption | during surgery and postoperative period up to 48th hours. | 
| Time of onset of narcotic analgesic need | (If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg. | during surgery and postoperative period up to 48th hours. | 
| Incidence of side effects | Incidence of nausea and vomiting | during surgery and postoperative period up to 48th hours. | 
| Incidence of quadriceps weakness | Physical examination for lower extremity | postoperative period up to 48th hours and postoperative in the first month | 
| Time until postoperative first mobilization | First mobilization time | Up to 48 hours | 
| Length of hospital stay | Hospitalization | Through study completion, an average of 1 week | 
| Beck depression inventory scores | (1-10 These ups and downs are considered normal, 11-16 Mild mood disturbance, 17-20 Borderline clinical depression, 21-30 Moderate depression, 31-40 Severe depression, Over 40 Extreme depression) | Will be done 3 times 1- on pre-operative hospitalization 2- in the hospital after surgery 3- in the 1st month follow-up after surgery | 
| Patient satisfaction | Satisfaction score; 0- very unsatisfied, 3- very satisfied | postoperative period up to 48th hours and postoperative in the first month | 
| Surgeon satisfaction | Satisfaction score; 0- very unsatisfied, 3- very satisfied | postoperative period up to 48th hours and postoperative in the first month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pericapsuler Nerve Group Block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale