Continuous Epidural Fentanyl- Low Dose Bupivacaine Infusion Analgesia for Precious Single Kidney Patient.

NCT03606902 | Completed

• 1 other identifier: R.18.01.4 - 20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Analgesia

Keywords

Epidural, Fentanyl, Kidney, Continuous, nephrotoxic.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• postoperative IV rescue analgesic

  total dose in the postoperative 1st 24hours

• Mean arterial blood pressure

  intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours

• Heart rate

  intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours

• puls oxymeter desaturation

  intraoperative every 1hour and every 2 hours for 1st postoperative 6 hours

• Ramsy sedation score

  basal and every 2 hours for the next 6 postoperative hours after recovery

Study Arms (2)

(Group f):

ACTIVE COMPARATOR

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

(Group Lf):

ACTIVE COMPARATOR

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

Interventions

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.

(Group f):

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)

(Group f):

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)

(Group Lf):

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.

(Group Lf):

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nephrectomy surgery
• ASA I-III
• Both sexes
• Age 18 - 65 years. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center-Mansoura Univeristy

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed A. ghanem, A.professor

  associate Professor of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: • double blinded randomized controlled study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blinded randomized controlled study

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: July 31, 2018
• Study Start: April 10, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-03

Locations

EG (1)