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Open surgical nephrectomy is associated with sever postoperative pain mandating alternative strong ,renal safety, minimal side effects, and minimal rescue systemic analgesics , continuous Epidural Fentanyl infusion in a dose step down tapering manner would produce hemodynamic stability with effective analgesia in nephrectomy surgery without using nephrotoxic analgesic drugs such as NSAIDs .The study proposal: Continuous Epidural Fentanyl infusion in a dose step down tapering manner with the least analgesic LA dose is enough intraoperative non nephrotoxic analgesic modality with good intraoperative(IO) Hemodynamic stability & less postoperative complications in patients subjected to nephrectomy surgery with remaining single precious kidney. Aim of the work: Intraoperative analgesic technique avoiding polymodal analgesia that utilize the nephrotoxic NSAIDs, To have a NSAIDs free surgery by using a Continuous IO effective & safe lipophilic opioid analgesia especially in nephrectomy surgery that leaves the patient with a single precious healthy kidney that has to be well perfused and totally protected from any nephrotoxic drugs with rapid recovery and less PO complications
• Introduction Open surgical nephrectomy is associated with sever postoperative pain mandating alternative strong ,renal safety, minimal side effects, and minimal rescue systemic analgesics , continuous Epidural Fentanyl infusion in a dose step down tapering manner would produce hemodynamic stability with effective analgesia in nephrectomy surgery without using nephrotoxic analgesic drugs such as NSAIDs .The study proposal: Continuous Epidural Fentanyl infusion in a dose step down tapering manner with the least analgesic LA dose is enough intraoperative non nephrotoxic analgesic modality with good intraoperative(IO) Hemodynamic stability & less postoperative complications in patients subjected to nephrectomy surgery with remaining single precious kidney. Aim of the work: Intraoperative analgesic technique avoiding polymodal analgesia that utilize the nephrotoxic NSAIDs, To have a NSAIDs free surgery by using a Continuous IO effective & safe lipophilic opioid analgesia especially in nephrectomy surgery that leaves the patient with a single precious healthy kidney that has to be well perfused and totally protected from any nephrotoxic drugs with rapid recovery and less PO complications. Material & Methods 50 adult patients, ASA I-III of both genders were randomly allocated into two groups each of 25 patients Control group (Group f):: using an epidural catheter technique with epidural catheter set, and at L1-2 insertion level directed up to cover up to T6 sensory level, Epidural injection of 15 ml total Volume of 0.0625%bupivacaine with 1µ/Kg/h Fentanyl for the 1st hour then 10ml of 0.0625% bupivacaine with 1µ/Kg/h Fentanyl for the next 5 hour then stop epidural infusion. Study group -Less Epidural Fentanyl group-(Group Lf): using an epidural catheter technique with epidural catheter set, and at L1-2 insertion level directed up to cover up to T6 sensory level, Epidural injection of 15 ml total Volume of 0.0625%bupivacaine with 1µ/Kg/h Fentanyl for the 1st hour then 10ml of 0.0625%bupivacaine with 0.5µ/Kg/h Fentanyl surgery then 3rd h 0.0625%bupivacaine with 0.25µ/Kg/h Fentanyl continue the same infusion volume and dose for the next 3 hours Preoperative preparation: After patient examination and consultation about any co-morbidities & explanation of the anesthetic procedures the consent will be taken after, clarification of VAS. Then 20 gage IV Catheter & Pre-loading by 500 ml Nacl0.9% solution over 30 minutes before anesthesia.
With the Patient in sitting position after skin disinfection and an 18-gauge epidural catheter was placed in the epidural space at T8-T9 or T9-T10 inter-space in both Groups of patients at T10-T11 or T11-T12 level, under local anesthesia, by an anesthesiology resident not involved in the study utilizing loss-of-resistance technique [9]. The study solutions were prepared by an anesthesiologist who was not involved in subsequent patient care or assessment. Using an epidural catheter set, to cover up to T6 sensory level, drug concentration 200 µ fentanyl (4ml)+ (5 ml) Bupivacaine 0.5% then add 31 ml sterile saline to have a total volume of 40 ml with concentration of 0.0625 with 5 µ fentanyl /ml of the cocktail solution. Then for every patient will calculate how much infusion will be based on body weight for example ( for a patient body weight 70kg ,1 µ/Kg/h infusion the volume will be 14 ml/h, 0.5 µ/Kg/h =7 ml/h,0.25 µ/kg/h =3.5 ml/h)
Call on-call anesthesia doctor if, RR<8, VAS>3, sedation score ≥3, systolic BP <100 mmHg, HR<50 B/minute Stop infusion if RR<8/min or sedation score=3-4, and if Priapism occur. Management …naloxone 0.1 mg IV bolus repeat every 5minutes till RR >10 and patient becomes responsive
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Group f): | Active Comparator | Intervention:
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| (Group Lf): | Active Comparator | Intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group f : Epidural catheter insertion | Procedure | Infiltrate the skin with local anesthetic lidocaine approximately 1 cm lateral to the inferior aspect of the targeted spinous process , epidural needle tip is midline at the junction of the lamina and spinous process . The needle is withdrawn and advanced with the same medial angle but in small increments cephalad to the same depth. Either bone or ligamentum flavum is contacted. If bone is contacted, the needle is redirected cephalad and advanced. If bone is no longer contacted and the depth exceeds the depth previously noted, the epidural needle stilette is removed. loss-of-resistance syringe is attached to the needle Once attained, stabilize the epidural needle and thread the catheter. Secure the catheter using a sterile locking device and adherent dressings. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain using 100mm VAS | postoperative pain during rest (lying supine), deep inspiration, coughing, and movement (getting up from supine to sitting position) using 100mm VAS | 6 hours of epidural infusion stopped compared to basal (just on stopping the infusion |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative IV rescue analgesic | postoperative analgesic request total dose | total dose in the postoperative 1st 24hours |
| Mean arterial blood pressure | intraoperative & postoperative |
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Inclusion Criteria:
Exclusion Criteria:
1-Patient refusal of epidural cathetar insrtion 2-Morbid obesity BMI>35 3- Hypersensitivity to amide local anesthetics, opioid fentanyl. 4-Contraindications to epidural anesthesia (coagulopathies), 5-Cardiac disease, hepatic disease, renal or respiratory failure, and Diseased both kidneys.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed A. ghanem, A.professor | associate Professor of Anesthesia and Surgical Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura Urology and Nephrology Center-Mansoura Univeristy | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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double blinded randomized controlled study
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• double blinded randomized controlled study.
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| Group F: Continous epidural infusion of bupivacaine plus fentanyl | Drug | Epidural injection of bolus of 15 ml total Volume of 0.0625%bupivacaine with 1 µg /Kg Fentanyl initial bolus, then from the 1st hour continuous epidural infusion of 0.0625% bupivacaine with µ/Kg/h Fentanyl fixed for the next 5 hour during operation and in the recovery room after recovery of general anesthesia then stop epidural infusion. (Total infusion time 6 hours=maximum hours needed for nephrectomy surgery) |
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| Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine | Drug | Epidural injection of bolus of 15 ml total Volume of 0.0625%bupivacaine with 1 µg/Kg Fentanyl initial bolus, then continuous IV infusion of 0.0625%bupivacaine with 1 µg/Kg/h Fentanyl for the 1st hour then continuous epidural infusion of 0.0625%bupivacaine with 0.5 µg/Kg/h Fentanyl during the 2nd hour, then 0.0625%bupivacaine with 0.25 µ g/Kg/h Fentanyl for the 3rd hour then continue the same infusion volume and dose (0.0625%bupivacaine with 0.25Mg/Kg/h Fentanyl) for the next 3 hours during operation and in the recovery room after recovery of general anesthesia then stop epidural infusion. (Total infusion time 6 hours=maximum hours needed for nephrectomy surgery) |
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| Group L f : Epidural catheter insertion | Procedure | Infiltrate the skin with local anesthetic lidocaine approximately 1 cm lateral to the inferior aspect of the targeted spinous process , epidural needle tip is midline at the junction of the lamina and spinous process . The needle is withdrawn and advanced with the same medial angle but in small increments cephalad to the same depth. Either bone or ligamentum flavum is contacted. If bone is contacted, the needle is redirected cephalad and advanced. If bone is no longer contacted and the depth exceeds the depth previously noted, the epidural needle stilette is removed. loss-of-resistance syringe is attached to the needle Once attained, stabilize the epidural needle and thread the catheter. Secure the catheter using a sterile locking device and adherent dressings. |
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| intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours |
| Heart rate | intraoperative & postoperative | intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours |
| puls oxymeter desaturation | intraoperative & postoperative | intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours |
| Ramsy sedation score | sedation scoreIf Awake Ramsey 1=Anxious, agitated, restless Ramsey 2=Cooperative, oriented, tranquil Ramsey 3=Responsive to commands only Ramsey 4=Brisk response to light glabellar tap or loud auditory stimulus Ramsey 5=Sluggish response to light glabellar tap or loud auditory stimulus Ramsey 6=No response to light glabellar tap or loud auditory stimulus | basal and every 2 hours for the next 6 postoperative hours after recovery |
| Modified Bromage score | 1 Complete block (unable to move feet or knees) 2 Almost complete block (able to move feet only) 3 Partial block (just able to move knees) 4 Detectable weakness of hip flexion while supine (full flexion of knees) 5 No detectable weakness of hip flexion while supine 6 Able to perform partial knee bend | basal every 2 hours for the next 6 postoperative hours after recovery |
| Postoperative itching | incidence yes or no | incidence during 1st 24 hours after surgery. |
| Postoperative Vomiting | incidence yes or no | incidence during 1st 24 hours after surgery. |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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