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The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.
It is a randomized controlled trial.
It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus Anterior Plan block plus fentanyl infusion | Active Comparator | The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion. |
|
| Fentanyl infusion only | Active Comparator | The patient will receive fentanyl infusion only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Anterior Plan Block+ Fentanyl infusion | Procedure | After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage. Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The total dose of postoperative operative fentanyl consumption in the first 24 hours. | The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total dosage of additional fentanyl boluses usage in micrograms intraoperatively | Total dosage of additional fentanyl boluses usage in micrograms intraoperatively | 12 months |
| First rescue analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED ISMAIL, Lecturer | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15668207 | Background | Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available. | |
| 11772793 | Background | Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003. |
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The patients data are confidential
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
|
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| Fentanyl | Drug | Continuous fentanyl infusion throughout the surgical procedure. |
|
Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.
| 12 months |
| Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6. | Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score. | 12 months |
| Intra and postoperative heart rate. | Intra and postoperative heart rate. | 12 months |
| Intraoperative and postoperative systolic blood pressure. | Intraoperative and postoperative systolic blood pressure. | 12 months |
| 11020770 | Background | Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. |
| 11825739 | Background | Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6. |
| 23923989 | Result | Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. |