Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443892
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-24
Brief Title:
Comparison of Pain Relief After Hip Fracture Surgery Hip and Groin Nerve Block
Sponsor:
Başakşehir Çam Sakura City Hospital
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Comparison of Postoperative Analgesic Efficacy of Pericapsular Nerve Block PENG and Suprainguinal Fascia Iliaca Compartment BlockSFICB in Intertrochanteric Femur Fractures
Status:
RECRUITING
Status Verified Date:
2024-05
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 observational prospective double-blind study aims to compare the analgesic effectiveness of the pericapsular nerve group block PENG group and the suprainguinal fascia iliaca compartment blockSFICB group to be applied to relieve postoperative pain in participants over the age of 18 who will be treated under spinal anesthesia with intertrochanteric femur fracture The main question it aims to answer is
Demonstration of whether PENG block or SFICB is more effective for postoperative analgesia in patients who have undergone intertrochanteric femur fracture surgery based on pain scores opioid consumption and patient satisfaction
ıntertrochanteric femur fractures cause severe pain with movement Postoperatively participants movements are severely restricted increasing the likelihood of complications
In this study participants pain status VAS score opioid consumption through patient-controlled analgesia and satisfaction will be measured with a survey at the end of the 24th hour
Demonstration of whether PENG block or SFICB is more effective for postoperative analgesia in patients who have undergone intertrochanteric femur fracture surgery based on pain scores opioid consumption and patient satisfaction
ıntertrochanteric femur fractures cause severe pain with movement Postoperatively participants movements are severely restricted increasing the likelihood of complications
In this study participants pain status VAS score opioid consumption through patient-controlled analgesia and satisfaction will be measured with a survey at the end of the 24th hour
Detailed Description:
Intertrochanteric femoral fracture accounts for approximately 45 to 50 of all hip fractures Intertrochanteric femur fractures cause severe pain with movement Postoperatively the movements of the participants are severely restricted which increases the risk of deep vein thrombosis in the lower extremities pulmonary infection and mortality in the participants
Peripheral nerve blocks have been shown to have less impact on hemodynamics respiratory function and consciousness than systemic pain relief options It is recommended as a first-line analgesia program especially for hip surgeries with its features of shortening postoperative recovery time reducing the risk of pneumonia and not hindering postoperative movement Fascia Iliaca compartment block used in this area is safe and widely used in postoperative hip fractures However to provide effective analgesia for hip surgery it is necessary to simultaneously block the femoral nerve lateral femoral cutaneous nerve and obturator nerve It has been reported that suprainguinal fascia iliaca compartment block does not provide adequate analgesia and does not reduce opioid consumption because the obturatory nerve cannot be blocked Therefore blocking the femoral nerve obturatory nerve and accessory obturatory nerves with PENG block has led to the idea that postoperative pain scores and opioid consumption will decrease significantly In this study we aim to compare the effectiveness of suprainguinal fascia iliaca compartment block and PENG block for postoperative analgesia based on pain scores and opioid consumption in intertrochanteric femur fractures
Pain is a symptom known to be subjective and in order to minimize differences between participants it will be questioned with the Numeric Rating Scale NRS which is a standardized scale
The total narcotic analgesic needs of the block-treated participants will be recorded with the PCA device inserted intravenously postoperatively and their total Tramadol consumption will be recorded
Mobilization start times and pain during the mobilization process will be questioned with the Turkish-American Pain Society Revised Patient Outcomes Survey
The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate participants satisfaction with pain management According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire whose Cronbachs Alpha value was calculated as 088 its three-factor structure was found to be appropriate The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients With this questionnaire 1 pain intensity and relief 2 the impact of pain on activity sleep and negative emotions 3 medication side effects 4 usefulness of pain management information5 ability to participate in pain management decisions and 6 the use of non-pharmacological techniques will be questioned
Demographic characteristics of the participants comorbidities operation times and complications will be recorded and analyzed statistically
Peripheral nerve blocks have been shown to have less impact on hemodynamics respiratory function and consciousness than systemic pain relief options It is recommended as a first-line analgesia program especially for hip surgeries with its features of shortening postoperative recovery time reducing the risk of pneumonia and not hindering postoperative movement Fascia Iliaca compartment block used in this area is safe and widely used in postoperative hip fractures However to provide effective analgesia for hip surgery it is necessary to simultaneously block the femoral nerve lateral femoral cutaneous nerve and obturator nerve It has been reported that suprainguinal fascia iliaca compartment block does not provide adequate analgesia and does not reduce opioid consumption because the obturatory nerve cannot be blocked Therefore blocking the femoral nerve obturatory nerve and accessory obturatory nerves with PENG block has led to the idea that postoperative pain scores and opioid consumption will decrease significantly In this study we aim to compare the effectiveness of suprainguinal fascia iliaca compartment block and PENG block for postoperative analgesia based on pain scores and opioid consumption in intertrochanteric femur fractures
Pain is a symptom known to be subjective and in order to minimize differences between participants it will be questioned with the Numeric Rating Scale NRS which is a standardized scale
The total narcotic analgesic needs of the block-treated participants will be recorded with the PCA device inserted intravenously postoperatively and their total Tramadol consumption will be recorded
Mobilization start times and pain during the mobilization process will be questioned with the Turkish-American Pain Society Revised Patient Outcomes Survey
The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate participants satisfaction with pain management According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire whose Cronbachs Alpha value was calculated as 088 its three-factor structure was found to be appropriate The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients With this questionnaire 1 pain intensity and relief 2 the impact of pain on activity sleep and negative emotions 3 medication side effects 4 usefulness of pain management information5 ability to participate in pain management decisions and 6 the use of non-pharmacological techniques will be questioned
Demographic characteristics of the participants comorbidities operation times and complications will be recorded and analyzed statistically
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