Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921110
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-04-30
Brief Title:
Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group PENG Block
Sponsor:
Ilker Ital
Organization:
Abant Izzet Baysal University
Study Overview
Official Title:
Evaluation of the Effectiveness of Two Different Bupivacaine Concentrations of Ultrasound-guided Postoperative PENG Block in Hip Operations Performed With Spinal Anesthesia
Status:
RECRUITING
Status Verified Date:
2023-06
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:
PENG
Brief Summary:
The use of regional anaesthesia techniques as part of multimodal analgesia in hip surgeries improves postoperative analgesia PENG Pericapsular nerve group block is an effective motor sparing analgesia technique used in hip surgeries The purpose of this study was to assess the efficacy of PENG block in terms of analgesic requirements and pain density in patients undergoing hip surgery using two different concentrations of local anaesthetic
Detailed Description:
Hip operations it is applied in femur fractures adjacent to the hip joint or in pathologies requiring reconstruction It is operated with general anesthesia or neuraxial anesthetic blocking methods Patients who are planned to heal bone and regain function with prosthesis after these operations are faced with acute pain due to surgical incisions and traumas in the postoperative period
Pharmacological treatment comes to the fore in pain management in patients who are admitted to the service after surgery Today multimodal pain treatment is recommended for postoperative analgesia and regional analgesia is a very important part of this Despite their side effects opioids are frequently used in patients with postoperative pain In patients who will undergo hip surgery apart from pharmacological methods methods such as neuraxial blocks spinal anesthesia epidural anesthesia are used Alternatively peripheral nerve blocks such as femoral nerve sciatic nerve lumbar plexus block 3 in 1 block acting on this area are applied With the increase in the use of ultrasound US the number and success of analgesic and anesthetic nerve blocks have increased Especially US guided field blocks such as erector spinae block suprainguinal fascia iliaca block pericapsular nerve group PENG block have become an important part of multimodal analgesia As the advantages of these blocks made with US technique is simple its application is practical and it is safe in terms of complications PENG block applied with US is one of the new methods local anesthetic drugs are injected into the fascia which is the transition region of the articular branches that receive the sensation of the hip joint
The aim of this study is to evaluate the analgesia levels of patients undergoing hip surgery by applying two different doses of PENG block after surgery Sixtysix patients with ASA I-III risk aged between 18-85 years who were planned for elective hip surgery under spinal anesthesia at Bolu AIBU Medical Faculty Hospital will be included in the study The patients will be randomly divided into 3 groups Group 025 Group 016 Group C Control randomized prospective using the randomizerorg website Patients will be informed about the study during the preoperative evaluation and information will be given about the visual analog pain scale VAS and Patient controlled analgesia PCA device to be used for postoperative analgesia Both verbal and written consent will be obtained After being taken to the operating table standard monitoring will be performed by opening a vascular access to all patients Anesthesia will be provided by spinal anesthesia from neuraxial blocks A total of 125-15 mg with a 25-27 G spinal needle from the L3-4 vertebral space to the patient 25-3 ml volume Heavy Bupivacaine 05 will be injected into the subarachnoid area and the success of the block will be checked and the surgical procedure will be started Ultrasound-guided PENG block will be applied to patients with postoperative PENG block at doses of 25 mgml and 16mgml in 20 ml volumes on the side of the operated hip depending on their groups In the control group only standard analgesic procedures will be applied In the patients to be treated asepsis-antisepsis will be applied in the supine position and the anterior inferior iliac process and iliopubic eminence tendon of the iliopsoas muscle will be visualized using the convex ultrasound probe Esaote MyLab 5 After the hydrodissection is made with 2 ml of physiological saline it will be seen that there is no air or blood with the help aspiration Local anesthetic solution will be applied and its distribution will be monitored No postoperative block procedure will be applied to the patients in Group C
Postoperative intravenous iv PCA will be applied to patients in all three groups For this Tramadol HCL Tramosel 100 mg2 ml Haver Pharma İlaç AŞ Istanbul continuous opioid infusion at 4mgml concentration is 2 mlhour at a maximum dose of 400mg within 24 hours with a 20-minute locking interval and bolus doses of 20 mg tramadol HCL will be administered iv each time the patient presses button Paracetamol 3x1000 mg iv will be applied Before the operation the patient will be told to press the button whenever he has pain VAS values at the 1st 2nd 4th 8th 12th 18th 24th hours after the operation SAP Systolic arterial pressure DAP Distolic arterial pressure MAP Mean arterial pressure HR Heart pulse rate SpO2 Peripheral oxygen saturation opioid consumption tramadol HCL at the 0-1 1-12 12-24 hours and patient satisfaction level before discharge whether there is motor loss or not will be registered If nausea vomiting pruritus allergy desaturation and other side effects occur in the patient follow-up they will be recorded Nausea vomiting will be treated with ondansetron iv rash and pruritus will be treated with feniramin hidrojen maleat iv When analgesia is insufficient 75 mg diclofenac sodium intramuscular im as a rescue analgesic when VAS is above 4 was planned
Pharmacological treatment comes to the fore in pain management in patients who are admitted to the service after surgery Today multimodal pain treatment is recommended for postoperative analgesia and regional analgesia is a very important part of this Despite their side effects opioids are frequently used in patients with postoperative pain In patients who will undergo hip surgery apart from pharmacological methods methods such as neuraxial blocks spinal anesthesia epidural anesthesia are used Alternatively peripheral nerve blocks such as femoral nerve sciatic nerve lumbar plexus block 3 in 1 block acting on this area are applied With the increase in the use of ultrasound US the number and success of analgesic and anesthetic nerve blocks have increased Especially US guided field blocks such as erector spinae block suprainguinal fascia iliaca block pericapsular nerve group PENG block have become an important part of multimodal analgesia As the advantages of these blocks made with US technique is simple its application is practical and it is safe in terms of complications PENG block applied with US is one of the new methods local anesthetic drugs are injected into the fascia which is the transition region of the articular branches that receive the sensation of the hip joint
The aim of this study is to evaluate the analgesia levels of patients undergoing hip surgery by applying two different doses of PENG block after surgery Sixtysix patients with ASA I-III risk aged between 18-85 years who were planned for elective hip surgery under spinal anesthesia at Bolu AIBU Medical Faculty Hospital will be included in the study The patients will be randomly divided into 3 groups Group 025 Group 016 Group C Control randomized prospective using the randomizerorg website Patients will be informed about the study during the preoperative evaluation and information will be given about the visual analog pain scale VAS and Patient controlled analgesia PCA device to be used for postoperative analgesia Both verbal and written consent will be obtained After being taken to the operating table standard monitoring will be performed by opening a vascular access to all patients Anesthesia will be provided by spinal anesthesia from neuraxial blocks A total of 125-15 mg with a 25-27 G spinal needle from the L3-4 vertebral space to the patient 25-3 ml volume Heavy Bupivacaine 05 will be injected into the subarachnoid area and the success of the block will be checked and the surgical procedure will be started Ultrasound-guided PENG block will be applied to patients with postoperative PENG block at doses of 25 mgml and 16mgml in 20 ml volumes on the side of the operated hip depending on their groups In the control group only standard analgesic procedures will be applied In the patients to be treated asepsis-antisepsis will be applied in the supine position and the anterior inferior iliac process and iliopubic eminence tendon of the iliopsoas muscle will be visualized using the convex ultrasound probe Esaote MyLab 5 After the hydrodissection is made with 2 ml of physiological saline it will be seen that there is no air or blood with the help aspiration Local anesthetic solution will be applied and its distribution will be monitored No postoperative block procedure will be applied to the patients in Group C
Postoperative intravenous iv PCA will be applied to patients in all three groups For this Tramadol HCL Tramosel 100 mg2 ml Haver Pharma İlaç AŞ Istanbul continuous opioid infusion at 4mgml concentration is 2 mlhour at a maximum dose of 400mg within 24 hours with a 20-minute locking interval and bolus doses of 20 mg tramadol HCL will be administered iv each time the patient presses button Paracetamol 3x1000 mg iv will be applied Before the operation the patient will be told to press the button whenever he has pain VAS values at the 1st 2nd 4th 8th 12th 18th 24th hours after the operation SAP Systolic arterial pressure DAP Distolic arterial pressure MAP Mean arterial pressure HR Heart pulse rate SpO2 Peripheral oxygen saturation opioid consumption tramadol HCL at the 0-1 1-12 12-24 hours and patient satisfaction level before discharge whether there is motor loss or not will be registered If nausea vomiting pruritus allergy desaturation and other side effects occur in the patient follow-up they will be recorded Nausea vomiting will be treated with ondansetron iv rash and pruritus will be treated with feniramin hidrojen maleat iv When analgesia is insufficient 75 mg diclofenac sodium intramuscular im as a rescue analgesic when VAS is above 4 was planned
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