Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568770
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Ease of SPINAL Positioning Between USG Guided Supra-inguinal Fascia Iliaca Block vs USG Guided Pericapsular Nerve Group Block in Patients Undergoing Femur Fracture Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the immediate and postoperative analgesic efficacy of S-FICB and PENG block will be the objective The use of ultrasonography in anesthesia has helped the anesthetist to see the nerve needle and the distribution of the drug thereby enhancing the chances of a favorable outcome of the nerve block Grade A recommendation for an ultrasound guided approach to the peripheral nerve blocks is supported by level Ib evidence for a shortened time for the onset of sensory block decreased performance time and lower drug doses10
Although individually both the blocks have been studied there are only a handful of studies comparing both techniques under ultrasound guidance for making patient positioning for spinal anesthesia easy And no local data is available comparing these blocks So we want to compare the analgesic efficacy of USG PENG block with USG S-FICB block in patients with fracture femur in reducing pain associated with positioning sitting for subarachnoid block duration of analgesia opioid sparing effect and complications So that procedure with better analgesic efficacy and less complications will be included in our local guidelines as a part of multimodal analgesia
Although individually both the blocks have been studied there are only a handful of studies comparing both techniques under ultrasound guidance for making patient positioning for spinal anesthesia easy And no local data is available comparing these blocks So we want to compare the analgesic efficacy of USG PENG block with USG S-FICB block in patients with fracture femur in reducing pain associated with positioning sitting for subarachnoid block duration of analgesia opioid sparing effect and complications So that procedure with better analgesic efficacy and less complications will be included in our local guidelines as a part of multimodal analgesia
Detailed Description:
Patients fulfilling the inclusion criteria will be included Patients will be optimized for dressing A detailed history will be taken regarding the mode of injury any pre-existing disease and previous surgery followed by the local examination of the patient will be done to rule out any systemic disease Informed consent will be taken These patients will be divided into 2 groups by Computer-generated random numbers and group assignment will be done by sequentially numbered opaque envelopes The envelope will be opened just before the procedure by the anaesthesiologist performing the block The observer another anaesthesiologist and patients will be unaware of the group and procedure performed Group A Supra-inguinal Fascia Iliaca Block and Group B Pericapsular Nerve Group Block The monitors of electrocardiogram pulse oximetry and non-invasive blood pressure in the preoperative area will be connected For drug and fluid administration an intravenous cannula of suitable size will be obtained Pre-procedural pain will be assessed during rest as well as on movement 15 passive elevation of the affected limb and will be recorded on numeric pain rating scale NRS 0 no pain 10 worst imaginable pain The blocks will be performed in supine position and strict sterile technique will be followed Both the blocks will be performed as per the standard technique The site to be blocked will be painted with 5 povidone-iodine followed by spirit and will be draped A linear 7-13 MHz ultrasonography probe ACUSON P500 digital colour doppler ultrasound Siemens Germany will be used with in-plane approach of needle Group S-FIB n 35 those who will receive a S-FIB with 20 mL of 05 bupivacaine and group PENG n 35 those who will receive a PENG with 20 mL of 05 bupivacaine Depending on the allotted group patients will be given the block under the guidance of ultrasound in the preoperative area by an experienced anesthesiologist with more than two years experience The PENG block will be performed as follows an ultrasound probe will be placed over the line joining anterior superior iliac spine ASIS and pubic tubercle PT keeping lateral margin at ASIS and adjusted the probe to get a sonoanatomic view for PENG block The needle entry point will be selected on the skin in such a manner that perpendicular needle entry will guide needle near target point iliopectineal eminence IPE The needle entry point will be anaesthetized with 2 ml 1 lidocaine and 22G 80mm stimuplex needle will be inserted out-of- plane to reach the bony rim near IPE avoiding injury to femoral nerve visible just lateral to femoral artery On bony contact 20 ml 05 bupivacaine will be injected slowly with repeated aspiration to avoid intravascular injection The correct needle position will be confirmed by drug spread under ilio-psoas muscle and then the rest of the drug volume will be injected The S-FIB will be given in a similar fashion With the patient in the proper position the skin will be disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca The transducer will be moved laterally until the sartorius muscle is identified As the needle will eventually pierce the fascia maybe a pop will be felt After negative aspiration 1-2 mL of local anesthetic will be injected to confirm the proper injection plane between the fascia and the ilio-psoas muscle A proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection as described After the spread of the drug will be seen the rest of the drug volume will be injected A numerical rating scale NRS pain score will be recorded before the block The onset time to achieve NRS pain score of 4 or less than 4 will be noted on prescribed proforma for both groups The patients will be made to sit for spinal anesthesia when the NRS score will be less than 4 after preloading with ringer lactate solution 80mlkg The spinal anaesthesia will be performed using 25G spinal needle with 075 bupivacaine solution 2ml in both groups The monitors of electrocardiogram pulse oximetry non-invasive blood pressure and urine output will be monitored according to ASA standard After completion of surgery patient will be shifted to respective ward where trained doctor and staff will monitor the patient The NRS score will be measured immediately postoperatively and at intervals of 2 hours for a period of 24 hours If the NRS score will be 4 rescue analgesia will be given an injection of paracetamol 15 mgkg will be given over a period of 10 to 15 minutes as an intravenous infusion and time will be noted Inj nalbuphine 01mgkg will be given for breakthrough pain Total dose of intravenous nalbuphine will be recorded in 1st 24hrs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None