Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130761
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-04-09
Brief Title:
Pericapsular Block Versus Trans Muscular Quadratus Lumborum Block in Patients Undergoing Correction of Hip Dysplasia
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Pericapsular Nerve Group Block Combined Versus Trans Muscular Quadratus Lumborum Block in Pediatric Patients Undergoing Correction of Dysplasia of the Hip a Prospective Randomized Double Blinded Study
Status:
RECRUITING
Status Verified Date:
2023-11
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 aim of our study to compare the analgesic effect of pericapsular nerve group block combined with lateral femoral cutaneous nerve block and trans muscular quadratus Lumborum Block block perioperatively in pediatric patients undergoing developmental dysplasia of the hip surgical repair
Detailed Description:
Patients of both study groups will be monitored using standard monitors Electrocardiogram pulse oximeter and automated non-invasive blood pressure NIBP After preoxygenation general anesthesia will be induced by a face mask and 8 sevoflurane and 100 oxygen then intravenous cannula will be inserted Fentanyl 1 µgkg will be given and after neuromuscular block is achieved with atracurium 05 mgkg and the trachea is intubated Anesthesia will be maintained with isoflurane 12 and 60 oxygen and the maintenance dose of atracurium 01 mgkg each 20 minutes Ringer lactate will be infused at 10 mlkg per hour in first hour then by the rule 4-2-1 ml per kg per hour
The blocks will be performed after induction of anesthesia and under ultrasound guidance using SonoSite M Turbo USA the scanning probe will be the linear multi-frequency 6-13 MHz transducer L25 x 6-13 MHz linear array
Patients will be randomly allocated into two equal groups PENG block P group and TQL block Q group
In PENG block group
With the patient in the supine position the skin is disinfected sterile drapes are used the transducer is wrapped with a sterile dressing and sterile ultrasound gel is used for scanning the transducer is placed in the transverse plane over the anterior inferior iliac spine AIIS and moved inferiorly to visualize the pubic ramus The femoral artery and iliopubic eminence are visualized and then using an in-plane technique a 22-gauge 50 mm needle is advanced from lateral to medial through the skin wheal at a 30-degree to 45-degree angle toward the ultrasound beam Aspiration will be performed before injection then 05 mlkg of 025 bupivacaine is deposited between the psoas tendon anteriorly and pubic ramus posteriorly lifting it 16 To perform the LFCN block again the patient in supine position the skin is disinfected sterile drapes are used the transducer is wrapped with a sterile dressing and sterile ultrasound gel is used for scanning the transducer is placed immediately inferior to the anterior superior iliac spine ASIS parallel to the inguinal ligament The tensor fasciae lata muscle TFLM and sartorius muscle SaM are then identified The nerve should appear as a small hypoechoic oval structure with a hyperechoic rim between the TFLM and SaM in a short-axis view or superficial to the SaM A 22-gauge 50 mm needle is inserted in-plane in a lateral-to-medial orientation through the subcutaneous tissue A fascial pop or click may be felt as the needle tip enters the plane between the TFLM and SaM To identify the needle tip position a volume of 05-1 mL of isotonic saline may be injected The correct position is achieved by visualizing the spread of 01 mlkg of 025 bupivacaine in the described plane between the TFLM and SaM or around the LFCN superficial to the SaM9 The dose of bupivacaine in both blocks should not exceed 25mg per kg as they will be administrated in the same patient
In TQL block group
With the patient in the lateral position the skin is disinfected sterile drapes are used the transducer is wrapped with a sterile dressing and sterile ultrasound gel is used for scanning the probe is used to recognize the three layers of abdominal wall muscles The transversus abdominis is traced more posteriorly until the transversus aponeurosis appears At this region usually we can find the peritoneum curves away from the muscles from anterior to posterior and the retroperitoneal fat is visualized Tilting the probe slightly caudal into the pelvis thus improves the view of the retroperitoneal fat and the tapered end of transversus aponeurosis QL is usually identified medial to the aponeurosis of transversus abdominis muscle vertically attached above the iliac crest A 22-gauge 50 mm needle will be inserted in the plane from the posterior edge of the convex probe through the QL in an anteromedial direction The needle tip will be placed between the PM muscle and the QL muscle and the local anesthetic will be injected into the fascial plane after aspiration test is negative A volume 05 mlkg of 025 bupivacaine is injected with maximum dose 25mg per kg of bupivacaine
In both groups The surgical stimulus will be delayed 15 minutes in both groups Intraoperative hemodynamics will be recorded at 10minute intervals If heart rate HR increases more than 20 an additional dose of fentanyl 1 µgkg will be given
By the end of surgery inhalational anesthesia will be discontinued and muscle relaxation will be reversed by atropine 002 mgKg and neostigmine 005 mgKg after the restoration of the patients spontaneous breathing The patient will be transferred to the post-anesthesia care unit PACU for 2 hours to complete recovery and monitoring Quality of analgesia will be assessed using face legs activity and cry consolability scale FLACC pain score18 on admission to PACU and then every 15 minutes for 2 hours After transfer to the ward FLACC pain score will be recorded at 3 6 12 and 24 hours postoperative
All patients will receive postoperative diclofenac sodium suppositories 1 mgkg approximated to available form 125 or 25 mg suppository every 8 hours Morphine IV will be given as rescue analgesia 005 mgkg in all study groups if the FLACC pain score Table 1 is more than 4 the maximum allowed dose will be 01mgkg every 4 hours
Any complications resulting from peripheral nerve blockade like local anesthetic systemic toxicity bleeding infection or neuropathy will be recorded and managed accordingly
The blocks will be performed after induction of anesthesia and under ultrasound guidance using SonoSite M Turbo USA the scanning probe will be the linear multi-frequency 6-13 MHz transducer L25 x 6-13 MHz linear array
Patients will be randomly allocated into two equal groups PENG block P group and TQL block Q group
In PENG block group
With the patient in the supine position the skin is disinfected sterile drapes are used the transducer is wrapped with a sterile dressing and sterile ultrasound gel is used for scanning the transducer is placed in the transverse plane over the anterior inferior iliac spine AIIS and moved inferiorly to visualize the pubic ramus The femoral artery and iliopubic eminence are visualized and then using an in-plane technique a 22-gauge 50 mm needle is advanced from lateral to medial through the skin wheal at a 30-degree to 45-degree angle toward the ultrasound beam Aspiration will be performed before injection then 05 mlkg of 025 bupivacaine is deposited between the psoas tendon anteriorly and pubic ramus posteriorly lifting it 16 To perform the LFCN block again the patient in supine position the skin is disinfected sterile drapes are used the transducer is wrapped with a sterile dressing and sterile ultrasound gel is used for scanning the transducer is placed immediately inferior to the anterior superior iliac spine ASIS parallel to the inguinal ligament The tensor fasciae lata muscle TFLM and sartorius muscle SaM are then identified The nerve should appear as a small hypoechoic oval structure with a hyperechoic rim between the TFLM and SaM in a short-axis view or superficial to the SaM A 22-gauge 50 mm needle is inserted in-plane in a lateral-to-medial orientation through the subcutaneous tissue A fascial pop or click may be felt as the needle tip enters the plane between the TFLM and SaM To identify the needle tip position a volume of 05-1 mL of isotonic saline may be injected The correct position is achieved by visualizing the spread of 01 mlkg of 025 bupivacaine in the described plane between the TFLM and SaM or around the LFCN superficial to the SaM9 The dose of bupivacaine in both blocks should not exceed 25mg per kg as they will be administrated in the same patient
In TQL block group
With the patient in the lateral position the skin is disinfected sterile drapes are used the transducer is wrapped with a sterile dressing and sterile ultrasound gel is used for scanning the probe is used to recognize the three layers of abdominal wall muscles The transversus abdominis is traced more posteriorly until the transversus aponeurosis appears At this region usually we can find the peritoneum curves away from the muscles from anterior to posterior and the retroperitoneal fat is visualized Tilting the probe slightly caudal into the pelvis thus improves the view of the retroperitoneal fat and the tapered end of transversus aponeurosis QL is usually identified medial to the aponeurosis of transversus abdominis muscle vertically attached above the iliac crest A 22-gauge 50 mm needle will be inserted in the plane from the posterior edge of the convex probe through the QL in an anteromedial direction The needle tip will be placed between the PM muscle and the QL muscle and the local anesthetic will be injected into the fascial plane after aspiration test is negative A volume 05 mlkg of 025 bupivacaine is injected with maximum dose 25mg per kg of bupivacaine
In both groups The surgical stimulus will be delayed 15 minutes in both groups Intraoperative hemodynamics will be recorded at 10minute intervals If heart rate HR increases more than 20 an additional dose of fentanyl 1 µgkg will be given
By the end of surgery inhalational anesthesia will be discontinued and muscle relaxation will be reversed by atropine 002 mgKg and neostigmine 005 mgKg after the restoration of the patients spontaneous breathing The patient will be transferred to the post-anesthesia care unit PACU for 2 hours to complete recovery and monitoring Quality of analgesia will be assessed using face legs activity and cry consolability scale FLACC pain score18 on admission to PACU and then every 15 minutes for 2 hours After transfer to the ward FLACC pain score will be recorded at 3 6 12 and 24 hours postoperative
All patients will receive postoperative diclofenac sodium suppositories 1 mgkg approximated to available form 125 or 25 mg suppository every 8 hours Morphine IV will be given as rescue analgesia 005 mgkg in all study groups if the FLACC pain score Table 1 is more than 4 the maximum allowed dose will be 01mgkg every 4 hours
Any complications resulting from peripheral nerve blockade like local anesthetic systemic toxicity bleeding infection or neuropathy will be recorded and managed accordingly
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