NephrectomyNCT03324490
Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
A study testing Thoracic Spinal Anesthesia, Thoracic Epidural Anesthesia and Bupivacaine 0.5% (hyperbaric) in people with Nephrectomy and Lung Diseases, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Patients with respiratory disease have an increased risk of developing complications perioperatively. The use of regional anesthesia decreases this risk with better postoperative outcome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nephrectomy, Lung Diseases, Anesthesia
- What is being tested?
- Thoracic Spinal Anesthesia, Thoracic Epidural Anesthesia and Bupivacaine 0.5% (hyperbaric)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class II or III
- Mild to moderate obstructive or restrictive lung disease
- Open nephrectomy candidate patients
Who cannot join
- Any condition contra-indicating regional anesthesia
- Allergic to any of the drugs used during the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Mid-thoracic Spinal Versus Epidural Anesthesia for Open Nephrectomy in Patients With Obstructive/Restrictive Lung Disease: A Randomized Controlled Study
Patients with respiratory disease have an increased risk of developing complications perioperatively. The use of regional anesthesia decreases this risk with better postoperative outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal versus thoracic epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease.
- Conditions
- Nephrectomy, Lung Diseases, Anesthesia
- Being tested
- Thoracic Spinal Anesthesia, Thoracic Epidural Anesthesia, Bupivacaine 0.5% (hyperbaric), Bupivacaine 0.5% (isobaric), Fentanyl
- Keywords
- Mid-thoracic spinal anesthesia, Mid-thoracic epidural anesthesia, Nephrectomy, Lung disease
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Spinal AnesthesiaProcedure or surgery
Spinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany).
When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) \& 5 μg dexmedetomidine will be injected.
Thoracic Epidural AnesthesiaProcedure or surgery
Epidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the "Prefix Custom Epidural Anesthesia Tray" with an 18 G Tuohy epidural needle \& a 20 G epidural catheter.
Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose \& continued throughout the procedure.
Bupivacaine 0.5% (hyperbaric)Drug
Also called Heavy Marcaine
Neuro-axially injected
Bupivacaine 0.5% (isobaric)Drug
Also called Marcaine
Neuro-axially injected
FentanylDrug
Neuro-axially injected
DexmedetomidineDrug
Neuro-axially injected
| Study group | Role | What they receive |
|---|---|---|
| TSA group | Active comparator | Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection Receives: Procedure: Thoracic Spinal Anesthesia; Drug: Bupivacaine 0.5% (hyperbaric); Drug: Fentanyl; Drug: Dexmedetomidine |
| TEA group | Active comparator | Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection Receives: Procedure: Thoracic Epidural Anesthesia; Drug: Bupivacaine 0.5% (isobaric); Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Score
Patient Satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent "E" (best score), fair "F" \& poor "P" (worst score).
Measured: 24 hours
Secondary outcomes (2)
VAS
Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain].
Measured: 12 hours
Mean ABP
Change in Mean Arterial Blood Pressure measured in mmHg.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Using computer \& sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia \[TSA group: n=30\] or thoracic epidural anesthesia \[TEA group: n=30\].
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Nazmy E Seif, MD, Study chair, Kasr Al-Ainy Hospital, Cairo UniversityAhmed M El-Badawy, MD, Study director, Kasr Al-Ainy Hospital, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324490
- Sponsor's protocol ID
- TSEANORLDP60
- Status last verified
- Jul 2019
- First submitted
- 18 Oct 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Mid-thoracic Spinal Versus Epidural Anesthesia for Open Nephrectomy in Patients With Obstructive/Restrictive Lung Disease: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03324490
- Acronym / sponsor ID
- TSEANORLDP60
- Conditions
- Nephrectomy, Lung Diseases, Anesthesia
- Keywords
- Mid-thoracic spinal anesthesia, Mid-thoracic epidural anesthesia, Nephrectomy, Lung disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with respiratory disease have an increased risk of developing complications perioperatively. The use of regional anesthesia decreases this risk with better postoperative outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal versus thoracic epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Using computer \& sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia [TSA group: n=30] or thoracic epidural anesthesia [TEA group: n=30].
| Arm | Type | Receives |
|---|---|---|
| TSA group | Active comparator | Procedure: Thoracic Spinal Anesthesia, Drug: Bupivacaine 0.5% (hyperbaric), Drug: Fentanyl, Drug: DexmedetomidineThoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection |
| TEA group | Active comparator | Procedure: Thoracic Epidural Anesthesia, Drug: Bupivacaine 0.5% (isobaric), Drug: FentanylThoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class II or III
- Mild to moderate obstructive or restrictive lung disease
- Open nephrectomy candidate patients
Key exclusion criteria (2 listed)
- Any condition contra-indicating regional anesthesia
- Allergic to any of the drugs used during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Spinal AnesthesiaSpinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany). When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) \& 5 μg dexmedetomidine will be injected. | Procedure or surgery | TSA group |
| Thoracic Epidural AnesthesiaEpidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the "Prefix Custom Epidural Anesthesia Tray" with an 18 G Tuohy epidural needle \& a 20 G epidural catheter. Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose \& continued throughout the procedure. | Procedure or surgery | TEA group |
| Bupivacaine 0.5% (hyperbaric)Also: Heavy MarcaineNeuro-axially injected | Drug | TSA group |
| Bupivacaine 0.5% (isobaric)Also: MarcaineNeuro-axially injected | Drug | TEA group |
| FentanylNeuro-axially injected | Drug | TEA group, TSA group |
| DexmedetomidineNeuro-axially injected | Drug | TSA group |
Primary outcome
Patient Satisfaction Score
Time frame: 24 hours
Patient Satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent "E" (best score), fair "F" \& poor "P" (worst score).
2 secondary outcomes
VAS
Time frame: 12 hours
Mean ABP
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazmy E Seif, MD study chair
Kasr Al-Ainy Hospital, Cairo University
Ahmed M El-Badawy, MD study director
Kasr Al-Ainy Hospital, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Spinal Anesthesia, Thoracic Epidural Anesthesia and Bupivacaine 0.5% (hyperbaric) in people with Nephrectomy and Lung Diseases, run by Nazmy Edward Seif 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 3 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 23 Jul 2019. 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?
Patient Satisfaction Score (time frame: 24 hours). 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 23 Jul 2019.