Postoperative PainNCT05898607
Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block
A study testing continuous Thoracic paravertebral block and continuous Erector spinae plane block in people with Postoperative Pain, run by Amal Gouda Elsayed Safan at 1 site in Egypt.
Trial summary
in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous TPVB and continuous ESPB) in relieving thoracotomy pain Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- continuous Thoracic paravertebral block and continuous Erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2023to 25 Jan 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible 40 patients will be older than 21 years old with American society of anesthesia physical status I\& II scheduled for elective thoracotomy
Who cannot join
- Patients who are:
- Uncooperative.
- Having allergy to any of the study drugs.
- Known abuse of alcohol or medication.
- Having Local infection at the site of injection or systemic infection.
- Pregnancy.
- With coagulation disorders or on anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoractomy
in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous TPVB and continuous ESPB) in relieving thoracotomy pain
Read the detailed description
General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98% and End tidal co2 Around 30-35 mmHg. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation after induction Group A: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative and Group B: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.
- Conditions
- Postoperative Pain
- Being tested
- continuous Thoracic paravertebral block, continuous Erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous Thoracic paravertebral blockOther
Also called TPVB
continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.
continuous Erector spinae plane blockOther
Also called ESPB
continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative Receives: Other: continuous Thoracic paravertebral block |
| Group B | Active comparator | Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative. Receives: Other: continuous Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy
visual analogue scale (VAS) Score
Measured: 48 hours
Secondary outcomes (5)
1 st call analgesia
mg
Measured: 1 hour
Total rescue opioid dose used
mg
Measured: 48 hour
patient satisfaction at 24 hours
Measured: 24 hours
occurrence of adverse events
Measured: 24hours
hospital stay
days
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start10 Feb 2023
- Primary completion10 Oct 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amal Gouda Elsayed Safan
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed Emad Basune, Wesam Eldin Sultan, Rabab Mohammed Habeeb
- Responsible party
- Sponsor-investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- Wesam Eldin Sultan, MD, Study director, Menoufia UniversityMohamed Emad Basune, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898607
- Sponsor's protocol ID
- 2/2023ANET10-25
- Status last verified
- Jan 2024
- First submitted
- 2 Jun 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoractomy
- ClinicalTrials.gov ID
- NCT05898607
- Acronym / sponsor ID
- 2/2023ANET10-25
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amal Gouda Elsayed SafanUniversity, hospital or other
- Collaborators
- Mohamed Emad Basune, Wesam Eldin Sultan, Rabab Mohammed Habeeb
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 12 Jun 2023 (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.
in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous TPVB and continuous ESPB) in relieving thoracotomy pain
Detailed description
General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98% and End tidal co2 Around 30-35 mmHg. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation after induction Group A: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative and Group B: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: continuous Thoracic paravertebral blockPatients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative |
| Group B | Active comparator | Other: continuous Erector spinae plane blockPatients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible 40 patients will be older than 21 years old with American society of anesthesia physical status I\& II scheduled for elective thoracotomy
Key exclusion criteria (7 listed)
- Patients who are:
- Uncooperative.
- Having allergy to any of the study drugs.
- Known abuse of alcohol or medication.
- Having Local infection at the site of injection or systemic infection.
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 |
|---|---|---|
| continuous Thoracic paravertebral blockAlso: TPVBcontinuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative. | Other | Group A |
| continuous Erector spinae plane blockAlso: ESPBcontinuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure | Other | Group B |
Primary outcome
Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy
Time frame: 48 hours
visual analogue scale (VAS) Score
5 secondary outcomes
1 st call analgesia
Time frame: 1 hour
Total rescue opioid dose used
Time frame: 48 hour
patient satisfaction at 24 hours
Time frame: 24 hours
occurrence of adverse events
Time frame: 24hours
hospital stay
Time frame: 1 week
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 26 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Wesam Eldin Sultan, MD study director
Menoufia University
Mohamed Emad Basune principal investigator
Menoufia 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 continuous Thoracic paravertebral block and continuous Erector spinae plane block in people with Postoperative Pain, run by Amal Gouda Elsayed Safan 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 1 inclusion and 7 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 26 Jan 2024. 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?
Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy (time frame: 48 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 26 Jan 2024.