Post Operative PainNCT05300854
Serratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief
A study testing Standard anesthesia in addition to serratus plane block and Standard anesthesia in addition to para-vertebral block in people with Post Operative Pain, run by Sohag University at 1 site in Egypt.
Trial summary
This double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. Patients were allocated into two equal groups (30 patients each). Group S: Standard anesthesia in addition to SPB. II. Group P: Standard anesthesia in addition to PVB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Standard anesthesia in addition to serratus plane block and Standard anesthesia in addition to para-vertebral block
- Type of treatment
- 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 Jan 2019to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients more than 18 ys undergoing thoracotomy operation
Who cannot join
- morbid obesity (Body mass index > 40)
- impossibility of anatomical structures US identification in a satisfactory way
- opioids treatment before surgery or substance abuse,
- sepsis and/or infection at the puncture sites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serratus Anterior Plane Block Versus Paravertebral Plane Block for Post Thoracotomy Pain Relief: A Comparative Study
This double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. Patients were allocated into two equal groups (30 patients each). Group S: Standard anesthesia in addition to SPB. II. Group P: Standard anesthesia in addition to PVB.
- Conditions
- Post Operative Pain
- Being tested
- Standard anesthesia in addition to serratus plane block, Standard anesthesia in addition to para-vertebral 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.
Standard anesthesia in addition to serratus plane blockProcedure or surgery
a US-guided SPB was performed after induction of general anesthesia with the patient lying supine.
Standard anesthesia in addition to para-vertebral blockProcedure or surgery
Standard anesthesia in addition to para-vertebral block
| Study group | Role | What they receive |
|---|---|---|
| Standard anesthesia in addition to serratus plane block | Active comparator | general anesthesia was given then ultrasound-guided serratus plane block Receives: Procedure: Standard anesthesia in addition to serratus plane block |
| Standard anesthesia in addition to para-vertebral block | Active comparator | general anesthesia was given then ultrasound-guided para-vertebral block Receives: Procedure: Standard anesthesia in addition to para-vertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of post-operative pain
reduction of visual analogue score
Measured: 72 hours
reduction of analgesic requirement
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ibraheem Darweesh, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300854
- Sponsor's protocol ID
- soh-Med-22-2-23
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2022
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block Versus Paravertebral Plane Block for Post Thoracotomy Pain Relief: A Comparative Study
- ClinicalTrials.gov ID
- NCT05300854
- Acronym / sponsor ID
- soh-Med-22-2-23
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 29 Mar 2022 (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.
This double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. Patients were allocated into two equal groups (30 patients each). Group S: Standard anesthesia in addition to SPB. II. Group P: Standard anesthesia in addition to PVB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard anesthesia in addition to serratus plane block | Active comparator | Procedure: Standard anesthesia in addition to serratus plane blockgeneral anesthesia was given then ultrasound-guided serratus plane block |
| Standard anesthesia in addition to para-vertebral block | Active comparator | Procedure: Standard anesthesia in addition to para-vertebral blockgeneral anesthesia was given then ultrasound-guided para-vertebral block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients more than 18 ys undergoing thoracotomy operation
Key exclusion criteria (4 listed)
- morbid obesity (Body mass index > 40)
- impossibility of anatomical structures US identification in a satisfactory way
- opioids treatment before surgery or substance abuse,
- sepsis and/or infection at the puncture sites
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 |
|---|---|---|
| Standard anesthesia in addition to serratus plane blocka US-guided SPB was performed after induction of general anesthesia with the patient lying supine. | Procedure or surgery | Standard anesthesia in addition to serratus plane block |
| Standard anesthesia in addition to para-vertebral blockStandard anesthesia in addition to para-vertebral block | Procedure or surgery | Standard anesthesia in addition to para-vertebral block |
Primary outcome
prevention of post-operative pain
Time frame: 72 hours
reduction of visual analogue score
reduction of analgesic requirement
Time frame: 72 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 29 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard anesthesia in addition to serratus plane block and Standard anesthesia in addition to para-vertebral block in people with Post Operative Pain, run by Sohag 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 1 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 29 Mar 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?
prevention of post-operative pain (time frame: 72 hours). The study lists 2 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 29 Mar 2022.