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Postoperative AnalgesiaNCT03606902

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

A study testing Group f : Epidural catheter insertion, Group F: Continous epidural infusion of bupivacaine plus fentanyl and Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine in people with Postoperative Analgesia, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Analgesia
What is being tested?
Group f : Epidural catheter insertion, Group F: Continous epidural infusion of bupivacaine plus fentanyl and Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
10 Apr 2018to 4 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura Urology and Nephrology Center-Mansoura Univeristy

    Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

Official title: Continuous Epidural Fentanyl Infusion Step-down Tapering Dose; Sole Intraoperative Analgesic Modality for Precious Single Kidney Patient.

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

Read the detailed description
  • 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)

  • Control group (Group f): Epidural injection of bolus of 15 ml total Volume of 0.0625%bupivacaine with 1µ/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.
  • Study group -Less Epidural Fentanyl group-(Group Lf): 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 0.25µ/Kg/h Fentanyl) for the next 3 hours during operation and in the recovery room after recovery of general anesthesia then stop epidural infusion.
  • Intraoperative management: After attaching basic monitoring NIBP cuff, Puls Oximeter probe, ECG, and EtCo2, Preoxygenation 5l O2 mask, for 5 minutes with the patient in sitting position with neck and upper back flexed. Widely prepare and drape the targeted thoracic segment(s) using sterile technique. Infiltrate the skin and subcutaneous tissues with local anesthetic approximately 1 cm lateral to the inferior aspect of the targeted spinous process with a 1.5- inch 25-gauge needle. With the infiltration needle, contact the ipsilateral lamina or transverse process and anesthetize the periosteum if possible. Perform local infiltration of subcutaneous tissues in both medial and cephalad directions to achieve adequate anesthesia of tissues at the intended path of the Tuohy needle and epidural catheter. Introduce the epidural needle with the bevel directed cephalad perpendicular to the anesthetized skin and advance until the ipsilateral lamina or transverse process is contacted. If lamina is not contacted, care may be taken to avoid advancing the needle laterally, which will place the needle in the paravertebral space. The needle depth to the lamina is then noted, and the needle is withdrawn back to skin and advanced again slightly medially; this step is repeated until the needle contacts bone at a slightly more superficial (approximately 2-5 mm) depth than the original depth at the lateral lamina. This suggests the epidural needle tip is midline at the junction of the lamina and spinous process (not shown). 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. The luer lock loss-of-resistance syringe is attached to the needle for loss of resistance. Once loss of resistance is attained, stabilize the epidural needle and thread the catheter. Secure the catheter using a sterile locking device and adherent dressings. (1)induction of General anesthesia using 1Mg/kg fentanyl then propofol 2mg/kg and roucronioum 0.5mg/kg then endotracheal tube (ETT) insertion in the trachea via glottis opening then starting mechanical ventilation with tidal volume (Tv) 7cm/kg, respiratory rate RR12, PEEP 7 and both TV\&RR can be changed up and down to adjust EtCo2 in the range (30-35)mmHg ,then roucuronum dosing of 0.2 of the original full bolus dose every 40 minutes and Inhalational anesthesia of Isoflurane 1MAC any incident of postoperative, Hypotension ( mean arterial blood pressure (MBP) less than 60 mmHg, will be managed by using ephedrine bolus doses of 6mg , 300ml colloid voluven and in case if sever bleeding >20% Blood volume loss blood and plasma transfusion according to patients requirements. Bradycardia (HR less than 60 b/m.) will be managed by atropine bolus of 0.5 mg. Desaturation (SaO2< 90%) will be managed by increase oxygen ventilation fraction and bilateral chest auscultation for chest wheezing and increased air way pressure to exclude bronchospasm at the end of operation reversal drugs to be given after attaining the recovery criteria and extubation to be done in a smooth safe non stressful situation. Pain during the study postoperative period the 1st 24 hours after recovery will be managed using IV pethidine 0.5mg/kg blouse without using NSAIDs.
  • Postoperative management: Monitoring NIBP, Puls, puls oximetry, ECG in the recovery room to complete 6 hours from the operation start time in the recovery room then sending the patient to the word .Pain will be assessed by VAS between 0 and 100 (0 representing no pain and 100 is the worst pain) postoperatively at 1,2, 6 hours. Total requirements of postoperative 1st 24 pethidine rescue analgesic requirement will be recorded Standing Orders for Epidural Combined Opioids and Local Anesthetic Infusions (nursing instructions) Keep IV access, don't remove. Hourly RR, sedation score, VAS, Dose administration 4hourly BLP HR, Temp. Priapism if occur requires immediate treatment 1st to stop epidural infusion. (A case is reported of a 45-year-old male patient in which a clear relation is demonstrated between continuous thoracic epidural analgesia and priapism after transabdominal nephrectomy.) (9)

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

Being tested
Group f : Epidural catheter insertion, Group F: Continous epidural infusion of bupivacaine plus fentanyl, Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine, Group L f : Epidural catheter insertion
Keywords
Epidural, Fentanyl, Kidney, Continuous, nephrotoxic.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group f : Epidural catheter insertionProcedure or 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.

  • Group F: Continous epidural infusion of bupivacaine plus fentanylDrug

    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 LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaineDrug

    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 L f : Epidural catheter insertionProcedure or 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.

Study groups in NCT03606902
Study groupRoleWhat they receive
(Group f):Active comparatorIntervention: 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 .
Receives: Procedure: Group f : Epidural catheter insertion; Drug: Group F: Continous epidural infusion of bupivacaine plus fentanyl
(Group Lf):Active comparatorIntervention: 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.
Receives: Drug: Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine; Procedure: Group L f : Epidural catheter insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 hours of epidural infusion stopped compared to basal (just on stopping the infusion

Secondary outcomes (8)
  1. postoperative IV rescue analgesic

    postoperative analgesic request total dose

    Measured: total dose in the postoperative 1st 24hours

  2. Mean arterial blood pressure

    intraoperative \& postoperative

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

  3. Heart rate

    intraoperative \& postoperative

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

  4. puls oxymeter desaturation

    intraoperative \& postoperative

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

  5. 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

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

  6. 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

    Measured: basal every 2 hours for the next 6 postoperative hours after recovery

  7. Postoperative itching

    incidence yes or no

    Measured: incidence during 1st 24 hours after surgery.

  8. Postoperative Vomiting

    incidence yes or no

    Measured: incidence during 1st 24 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start10 Apr 2018
  3. Primary completion4 Dec 2018
  4. Study completion4 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
double blinded randomized controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606902
Sponsor's protocol ID
R.18.01.4 - 20
Status last verified
Mar 2018
First submitted
7 Jul 2018
Last updated
5 Dec 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Group f : Epidural catheter insertion, Group F: Continous epidural infusion of bupivacaine plus fentanyl and Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine in people with Postoperative Analgesia, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain using 100mm VAS (time frame: 6 hours of epidural infusion stopped compared to basal (just on stopping the infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.

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