An interventional study of Group f : Epidural catheter insertion and Group F: Continous epidural infusion of bupivacaine plus fentanyl in Postoperative Analgesia, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
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
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
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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Intervention: 1. Procedure: Epidural catheter insertion 2. Drug: Epidural 15 ml of 0.0625%bupivacaine with 1 µg /Kg Fentanyl ,then continuous epidural infusion of fixed volume 10 ml of 0.0625% bupivacaine +1 µg/Kg/h Fentanyl for the next 6 hours .
Procedure: Group f : Epidural catheter insertion · Drug: Group F: Continous epidural infusion of bupivacaine plus fentanyl
Intervention: 1. Procedure:Epidural catheter insertion 2. Drug: Epidural injection 15 ml of 0.0625%bupivacaine with 1 µg/Kg Fentanyl initial bolus, then 1st hour continuous IV infusion of 10ml of 0.0625%bupivacaine +1 µg/Kg/h Fentanyl ,2nd hour 10ml of 0.0625%bupivacaine + 0.5 µg/Kg/h Fentanyl , then next 4 hours10 ml of 0.0625%bupivacaine with + 0.25 µ g/Kg/h Fentanyl.
Drug: Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine · Procedure: Group L f : Epidural catheter insertion
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.
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)
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)
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.
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
Time frame: 6 hours of epidural infusion stopped compared to basal (just on stopping the infusion
postoperative IV rescue analgesic
postoperative analgesic request total dose
Time frame: total dose in the postoperative 1st 24hours
Mean arterial blood pressure
intraoperative \& postoperative
Time frame: intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours
Heart rate
intraoperative \& postoperative
Time frame: intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours
puls oxymeter desaturation
intraoperative \& postoperative
Time frame: 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
Time frame: 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
Time frame: basal every 2 hours for the next 6 postoperative hours after recovery
Postoperative itching
incidence yes or no
Time frame: incidence during 1st 24 hours after surgery.
Postoperative Vomiting
incidence yes or no
Time frame: incidence during 1st 24 hours after surgery.
Plan to share: Undecided
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Solitary Kidney
Mansoura University