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This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Effective postoperative pain control in children remains a clinical challenge, and regional anesthesia techniques such as the ESP block have shown promise in improving outcomes.
In this randomized, double-blind clinical trial, pediatric patients scheduled for elective lower abdominal surgeries will be assigned to receive either bupivacaine alone or bupivacaine combined with dexmedetomidine as part of an ultrasound-guided ESP block. The primary outcome is the duration of postoperative analgesia, defined as the time from the block until the first request for rescue analgesia. Secondary outcomes include total analgesic consumption and postoperative pain scores
Preoperative setting:
Intraoperative setting:
All children will be premedicated orally with midazolam (0.05-0.1 mg/kg over 2-3 minutes, maximum 6 mg) 30 minutes prior to surgery. On arrival of the patients to the operative room, routine monitoring with 5-leads electrocardiogram (ECG), non-invasive blood pressure (NIBP) and pulse oximetry will be instituted, then anesthesia will be induced with 8% sevoflurane in 100% oxygen. After an adequate depth of anesthesia is reached, an intravenous access will be placed under aseptic condition, then all patients will receive intravenous (IV) fentanyl (1 µg/kg) and atracurium (0.5 mg/kg), and orotracheal endotracheal intubation will be performed. Anesthesia will be maintained with a mixture of oxygen-air (50% - 50%) and isoflurane
-1.5%). Muscle relaxation will be sustained during the procedure with incremental doses of IV atracurium (0.1 mg/kg) every 25 minutes.
In group A: US guided ESPB will be performed with aseptic precautions using a (6- 19) MHz linear probe in a sterile cover with sterile jelly (GE LOGIQ 5, USA).
Technique of US guided ESPB block: The block will be performed by a trained anesthetist in regional anesthetic techniques while the patient in lateral position, the ultrasound transducers will be placed in a parasagittal plane 2-3 cm away from the midline at the level of first lumbar vertebra (L1) (The L1 level will be identified by counting upwards from the sacrum). Sliding the transducer medially till identifying the transverse process which appear as flat acoustic shadow and after identification of erector spinae muscle (ESM) and transverse process, a 22-gauge 50 mm echogenic block needle (Sono Plex® PAJUNK®, Germany) will be introduced in cranio-caudal direction with in-plane technique and after confirming the position of the tip of the needle over the transverse process with negative aspiration to blood or air, Bupivacaine 0.25% (with a maximum dose 2 mg/kg) plus Dexmedetomidine (0.5µg/kg), putting into consideration that the total volume to be 0.3 ml/kg on each side, will be injected. The spread of local anesthetic in a plane below the erector spinae muscle will be visualized.
The skin incision will be made 15 min after the block.
Baseline values of heart rate (HR) and mean blood pressure (MAP) will be recorded before skin incision and then recorded at 5, 30, 60 minutes after skin incision and at the end of surgery. Also, patients will be monitored for sign of local anesthetic toxicity.
Any complications related to the block given will be recorded including hematoma, intravascular injection, and allergic reactions.
If local anesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 1.5 ml/kg over 2-3 min will be given.
In group B: This group will receive ESPB using Bupivacaine 0.25% (with a maximum dose 2 mg/kg) alone 15 min before skin incision with the same protocol and precautions.
Postoperative setting:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine Group | Active Comparator | Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with bupivacaine only. |
|
| Bupivacaine + Dexmedetomidine Group | Experimental | Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with a combination of bupivacaine and dexmedetomidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine will be used in an ESP block to provide postoperative analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Postoperative Analgesia | Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia. | Up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores |
| At 1, 2, 4, 6, 12, and 24 hours after surgery |
| Total intraoperative analgesics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed G Nowar, MBBCH | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt | 11865 | Egypt |
All data will be shared once study is completing
Before 1/2026
Free
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Dexmedetomidine | Drug | Dexmedetomidine will be added to bupivacaine in the ESP block to evaluate its effect on duration of postoperative analgesia. |
|
|
Total intraoperative fentanyl consumption in micrograms |
| During the operation from the induction of anesthesia until the recovery. |
| Total Postoperative Analgesic Consumption | The total amount (in milligrams) of rescue analgesics administered to the patient within the first 24 hours after surgery. | Within 24 hours postoperatively |
| Incidence of Adverse Effects | The occurrence of adverse effects such as sedation, nausea, vomiting, bradycardia, or hypotension within 24 hours after surgery. | Within 24 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |