Pulmonary FunctionNCT03885583
Post-operative Pulmonary Function After Kidney Surgery Under Two Different Techniques
A study testing thoracic epidural block and paravertebral block in people with Pulmonary Function, run by Assiut University at 1 site in Egypt.
Trial summary
To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Function
- What is being tested?
- thoracic epidural block and paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 30 Nov 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA II, III
- elective kidney surgery
Who cannot join
- patient refusal
- contraindications to neuraxial blocks
- pneumonectomy
- planed postoperative mechanical ventilatoin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-operative Pulmonary Function After Open Kidney Surgery: Comparison Between Thoracic Epidural and Paravertebral Block
To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery
Read the detailed description
Study tools
- An Ultrasound machine (Madison X6) with superficial linear and curved probe.
- A 19 gauge echogenic needle and Plexolong Cather (PAJUNK, Plexolong Meier nanoline, Geisingen, Germany; 60 mm).
- A 17-gauge Tuohy needle and 19 G flex-tip catheter: for thoracic epidural.
- Spirometer: (Enraf-Nonius, Model SPIRO 601).
- Drugs: isobaric bupivacaine 0.25% (aside from the drugs used in the standard operation theatre).
- Computer software: computer generated random tables (for randomization) and SPSS 22 (for data analysis)
Thoracic epidural (TEP):
A pre-procedural ultrasound examination will be done to first identify the correct targeted thoracic level. To accomplish this, the transducer will be placed in the parasagittal plane approximately 5 cm from midline. The thoracic level will be determined by identifying the 12th rib and counting in a cephalad direction until the targeted level is marked.
All epidurals will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheters will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection
Bupivacaine 0.25% of 7.5-12 ml volume will be given through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h with bolus infusion of 5 to 10 ml of the infusion mixture for breakthrough pain. The block height will be tested using pin prick method. After spirometry testing and diaphragmatic ultrasound, the infusion of TEP will be gradually weaned of and the catheter will be removed under complete aseptic precautions.
Thoracic paravertebral block: (TPVB) The Ultrasound-probe will be centered on T7. The sagittal technique at the transverse process, in-plane, will be used. The 19 gauge echogenic needle will be inserted in-plane at the lower border of the transducer and advanced in a cephalad position with real-time ultrasound sonography.
Injection of small amounts of fluid (hydro-dissection) will aid in needle tip location. When the needle tip reaches the paravertebral space, 7.5-12 ml Bupivacaine 0.25% will be slowly injected after negative aspiration. The endpoint for a successful block is anterior displacement of the pleura. The catheter will be then inserted through the needle and positioned up to 3 cm from skin entry directing upwards in the paravertebral space then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h with bolus infusion of 5 to 10 ml of the infusion mixture for breakthrough pain.
- Conditions
- Pulmonary Function
- Being tested
- thoracic epidural block, paravertebral block
- Keywords
- kidney surgery, thoracic epidural block, paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural blockProcedure or surgery
thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound
paravertebral blockProcedure or surgery
paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound
| Study group | Role | What they receive |
|---|---|---|
| thoracic epidural group | Active comparator | patients in this group will receive ultrasound guided thoracic epidural block preoperatively for pain management, continuous infusion of 0.5% bupivacaine through epidural catheter during operation and early post-operative period Receives: Procedure: thoracic epidural block |
| paravertebral group | Active comparator | patients in this group will receive ultrasound guided pararvertebral block preoperatively for pain management, continuous infusion of paravertebral bupivacaine 0.5% through paravetebral catheter during operation and early post-operative period Receives: Procedure: paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital capacity
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
Measured: 24 hours after operation
forced vital capacity
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
Measured: 24 hours after operation
forced expiratory volume in one second
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)
Measured: 24 hours after operation
Secondary outcomes (2)
pain score
pain will be assessed using VAS score, it provides a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 24 hours after operation
diaphragmatic excursion
ultrasound assessment of diaphragmatic excursion
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 May 2019
- Primary completion29 Aug 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelbaky Abdelrahman, Assiut University
- Investigators
- Mohammed G Abdelraheem, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885583
- Sponsor's protocol ID
- aunanesth202019
- Status last verified
- Nov 2022
- First submitted
- 20 Mar 2019
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pulmonary Function After Open Kidney Surgery: Comparison Between Thoracic Epidural and Paravertebral Block
- ClinicalTrials.gov ID
- NCT03885583
- Acronym / sponsor ID
- aunanesth202019
- Conditions
- Pulmonary Function
- Keywords
- kidney surgery, thoracic epidural block, paravertebral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 21 Mar 2019 (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.
To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery
Detailed description
Study tools
- An Ultrasound machine (Madison X6) with superficial linear and curved probe.
- A 19 gauge echogenic needle and Plexolong Cather (PAJUNK, Plexolong Meier nanoline, Geisingen, Germany; 60 mm).
- A 17-gauge Tuohy needle and 19 G flex-tip catheter: for thoracic epidural.
- Spirometer: (Enraf-Nonius, Model SPIRO 601).
- Drugs: isobaric bupivacaine 0.25% (aside from the drugs used in the standard operation theatre).
- Computer software: computer generated random tables (for randomization) and SPSS 22 (for data analysis)
Thoracic epidural (TEP):
A pre-procedural ultrasound examination will be done to first identify the correct targeted thoracic level. To accomplish this, the transducer will be placed in the parasagittal plane approximately 5 cm from midline. The thoracic level will be determined by identifying the 12th rib and counting in a cephalad direction until the targeted level is marked.
All epidurals will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheters will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection
Bupivacaine 0.25% of 7.5-12 ml volume will be given through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h with bolus infusion of 5 to 10 ml of the infusion mixture for breakthrough pain. The block height will be tested using pin prick method. After spirometry testing and diaphragmatic ultrasound, the infusion of TEP will be gradually weaned of and the catheter will be removed under complete aseptic precautions.
Thoracic paravertebral block: (TPVB) The Ultrasound-probe will be centered on T7. The sagittal technique at the transverse process, in-plane, will be used. The 19 gauge echogenic needle will be inserted in-plane at the lower border of the transducer and advanced in a cephalad position with real-time ultrasound sonography.
Injection of small amounts of fluid (hydro-dissection) will aid in needle tip location. When the needle tip reaches the paravertebral space, 7.5-12 ml Bupivacaine 0.25% will be slowly injected after negative aspiration. The endpoint for a successful block is anterior displacement of the pleura. The catheter will be then inserted through the needle and positioned up to 3 cm from skin entry directing upwards in the paravertebral space then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h with bolus infusion of 5 to 10 ml of the infusion mixture for breakthrough pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic epidural group | Active comparator | Procedure: thoracic epidural blockpatients in this group will receive ultrasound guided thoracic epidural block preoperatively for pain management, continuous infusion of 0.5% bupivacaine through epidural catheter during operation and early post-operative period |
| paravertebral group | Active comparator | Procedure: paravertebral blockpatients in this group will receive ultrasound guided pararvertebral block preoperatively for pain management, continuous infusion of paravertebral bupivacaine 0.5% through paravetebral catheter during operation and early post-operative period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA II, III
- elective kidney surgery
Key exclusion criteria (4 listed)
- patient refusal
- contraindications to neuraxial blocks
- pneumonectomy
- planed postoperative mechanical ventilatoin
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 epidural blockthoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound | Procedure or surgery | thoracic epidural group |
| paravertebral blockparavertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound | Procedure or surgery | paravertebral group |
Primary outcome
vital capacity
Time frame: 24 hours after operation
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
forced vital capacity
Time frame: 24 hours after operation
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
forced expiratory volume in one second
Time frame: 24 hours after operation
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)
2 secondary outcomes
pain score
Time frame: 24 hours after operation
diaphragmatic excursion
Time frame: 24 hours after operation
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 2 Dec 2022.
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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.
Mohammed G Abdelraheem, MD study director
Assiut 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 epidural block and paravertebral block in people with Pulmonary Function, run by Assiut 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 2 inclusion and 4 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 2 Dec 2022. 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?
vital capacity (time frame: 24 hours after operation). The study lists 3 primary outcomes in all. 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 2 Dec 2022.