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To compare between the intra muscular quadratous lamborum and the Trans muscular quadratous lamborum in pediatric population under going abdominal surgeries regards to first request of rescue analgesia, degree of pain relief, effect on hemo dynamic stability and incidence of complications.
The investigators hypothesized that an ultrasound guided quadratous lamborum block would prove successful peri-operative analgesia for abdominal surgeries in pediatric patients, and that Intra muscular quadratous lamborum is non inferior to Trans muscular blockade with the advantage of being safer (away from the peritoneum and retroperitoneal organs) and with the assumption that sarcolemmal layer in pediatrics should not resist the diffusion of the injectant from within the muscle out, to reach the inter fascial plane where the targeted nerves are found and cause an efficient blockade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans Muscular Quadratus Lumborum fascial plane Block | Active Comparator | In group (Trans Muscular Quadratus Lumborum Block),will undergo ultrasound guided trans-muscular quadratus lamborum block as follows: A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoas Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg per side of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side. |
|
| Intra Muscular Quadratus Lumborum fascial plane Block | Active Comparator | In group Intra Muscular Quadratus Lumborum Block ,will undergo ultrasound guided intra-muscular quadratus lamborum (QL) block as follows: A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg per side of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side. |
|
| group c → control | Placebo Comparator | group c → control ,will receive conventional analgesia in the form of paracetamol with 15 mg\ k.g every 6 hours, and naluphin 0.1 mg \kg on demands |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block. | Procedure | A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoa Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of the first postoperative analgesic request | (duration of the block, time spent post-operative before rescue opioid is needed at pain score of 6 or higher, up to 12 hours post operative. | starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| total opioid consumption over the first 12 hours. | rescue analgesia in the form of intravenous nalbuphine 0.1 milligram/Kilogram will be given for a Wong-Baker Faces Scale more than 4 up to 12 hours post operative. | through out the first 12 hours post operative. |
| Pain score up to 12 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| patient's heart rate | heart rate will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area. | starting from 5 minutes after intubation till 30 minutes after extubation |
Inclusion Criteria:
Exclusion Criteria:
Refusal of regional block or patients requiring emergency procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abu ElReesh hospital, Cairo university Hospital,Kasr Alini | Cairo | 11562 | Egypt |
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age:5-12, American Society of Anesthesia I-III, abdominal laparoscopies, randomly allocated into one of the study groups, randomization sequence will be concealed in sealed envelopes with alphabetic codes. The identifiers will be attached to the opened envelopes and secured by dedicated person independent of randomization proceedings. Patients, parents and data analysts will be blinded to group assignments.
The groups:
The alpha error is set at 0.05 and the study power is 0.95.
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Patients, parents and data analysts will be blinded to group assignments.
|
| Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block. | Procedure | A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side. |
|
| Control | Procedure | Conventional analgesia |
|
Postoperative pain score for each patient will be assessed by Wong-Baker Faces Scale at the following intervals: 15, 30, and 60 min, 6, and 12 hours after surgery. |
| through out the first 12 hours post operative. |
| Block failure | a failed block is where the patient requires more than two doses of rescue analgesia in the first hour postoperatively | through out the first hour post operative. |
| Ease of performance of each technique | Easiness of performance of the technique, rated on a simple verbal scale easy/moderately difficult/difficult) and defined as follows:
| through out the block performance time |
| Block performance time | Block performance time in minutes which is the time from probe contact with skin till needle withdrawal | starting from probe contact with skin till 30 minutes. |
| The incidence of post block adverse effects | incidence of complications, such as:
| starting after the block is given up to the first 12 hours post operative |
| patient's systolic blood pressure | systolic blood pressure will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area. | starting from 5 minutes after intubation till 30 minutes after extubation |
| patient's diastolic blood pressure | diastolic blood pressure will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area. | starting from 5 minutes after intubation till 30 minutes after extubation |
| intraoperative administration of extra analgesic dose of fentanyl | Number of patients in each group who needed intraoperative administration of extra analgesic dose of fentanyl 0.5 microgram/kilogram),in patients showing increase in heart rate and/or arterial blood pressure 10 minutes after returning to supine position after the block is given, by more than 20% of baseline values (5 minutes after intubation) in response to surgical stimulus or thereafter throughout the whole operation. | starting from 10 minutes after the chosen block is given till extubation. |
| Duration of surgery | time in minutes from skin incision till skin closure | starting from skin incision up to skin closure. |
| Duration of general anesthesia | time in minutes from induction of GA till extubation | starting from induction of anesthesia till extubation |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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