Postoperative PainNCT04697420
Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries
A study testing Thoracic paravertebral block and Transversus abdominis plane block in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of many post operative complications . There are a lot of regional anesthetic techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Thoracic paravertebral block and Transversus abdominis plane block
- 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 23 Jan 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 - 60 years
- ASA I-II class
Who cannot join
- Patient refusal
- Any contraindication of regional anesthesia block (Coagulopathy,infection at the needle insertion site)
- Patients with allergy to amide local anesthetics or medication included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane Block Versus Paravertebral Block for Post-operative Pain Relief Following Open Renal Surgeries: a Randomized Clinical Trial
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of many post operative complications .
There are a lot of regional anesthetic techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block.
TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries.It is safer technique than PVB, but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .
Read the detailed description
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of post operative respiratory complications . A lot of patients presented to these operations may have comorbidities as impaired renal function and respiratory problems , conditions like these may contraindicate aministration of systemic analgesia as opioids .
There are a lot of techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block .
Paravertebral block is effective technique for post operative analgesia for upper abdominal surgeries , but it may be associated with some complications as : pneumothorax , spread of local anesthetic to the epidural space and paravertebral blood vessels , and this may lead to systemic toxicity of local anesthetic .
TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries , but it is safer technique than PVB , but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .
- Conditions
- Postoperative Pain
- Being tested
- Thoracic paravertebral block, Transversus abdominis 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.
Thoracic paravertebral blockProcedure or surgery
Thoracic paravertebral block is a technique in which , the local anesthetic agent is injected in the paravertebral space to anesthetise the spinal nerves after emerging from the vertebral canal in order to provide analgesia in the thoracic and upper abdominal area .
Transversus abdominis plane blockProcedure or surgery
Transversus abdominis plane block is a technique is mostly done under ultrasound guidance to identify the transversus plane between the internal oblique muscle and the transverses abdominis muscle , the space in which the neurovascular supply of the anterior abdominal wall is present , and hence the injection of local anesthetic agent in this space results in anesthesia of the anterolateral aspect of the abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Group (P) | Experimental | the patients were received paravertebral block to control pain postoperatively. Receives: Procedure: Thoracic paravertebral block |
| Group (T) | Experimental | the patients were received transversus abdomins plane (TAP) block to control pain postoperatively. Receives: Procedure: Transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block by the following assessment methods: Visual Analogue Scale score (VAS) immediately postoperative and through the first 24 hours postoperativly, total analgesic consumption through the first 24 hours postoperatively, and time of first analgesic request in the postoperative period
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Nov 2017
- Primary completion24 Oct 2018
- Study completion23 Jan 2019
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Hussein Ali, Assiut University
- Investigators
- Essam Ezzat, Professor, Study director, Professor of anesthesia, intensive care and pain management , formerly head of the department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697420
- Sponsor's protocol ID
- AHAAssiut
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2020
- Last updated
- 1 Feb 2023
- Results posted
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block Versus Paravertebral Block for Post-operative Pain Relief Following Open Renal Surgeries: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04697420
- Acronym / sponsor ID
- AHAAssiut
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 6 Jan 2021 (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.
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of many post operative complications .
There are a lot of regional anesthetic techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block.
TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries.It is safer technique than PVB, but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .
Detailed description
Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of post operative respiratory complications . A lot of patients presented to these operations may have comorbidities as impaired renal function and respiratory problems , conditions like these may contraindicate aministration of systemic analgesia as opioids .
There are a lot of techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block .
Paravertebral block is effective technique for post operative analgesia for upper abdominal surgeries , but it may be associated with some complications as : pneumothorax , spread of local anesthetic to the epidural space and paravertebral blood vessels , and this may lead to systemic toxicity of local anesthetic .
TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries , but it is safer technique than PVB , but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (P) | Experimental | Procedure: Thoracic paravertebral blockthe patients were received paravertebral block to control pain postoperatively. |
| Group (T) | Experimental | Procedure: Transversus abdominis plane blockthe patients were received transversus abdomins plane (TAP) block to control pain postoperatively. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18 - 60 years
- ASA I-II class
Key exclusion criteria (3 listed)
- Patient refusal
- Any contraindication of regional anesthesia block (Coagulopathy,infection at the needle insertion site)
- Patients with allergy to amide local anesthetics or medication included in the study.
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 paravertebral blockThoracic paravertebral block is a technique in which , the local anesthetic agent is injected in the paravertebral space to anesthetise the spinal nerves after emerging from the vertebral canal in order to provide analgesia in the thoracic and upper abdominal area . | Procedure or surgery | Group (P) |
| Transversus abdominis plane blockTransversus abdominis plane block is a technique is mostly done under ultrasound guidance to identify the transversus plane between the internal oblique muscle and the transverses abdominis muscle , the space in which the neurovascular supply of the anterior abdominal wall is present , and hence the injection of local anesthetic agent in this space results in anesthesia of the anterolateral aspect of the abdominal wall. | Procedure or surgery | Group (T) |
Primary outcome
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block
Time frame: 24 hours
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block by the following assessment methods: Visual Analogue Scale score (VAS) immediately postoperative and through the first 24 hours postoperativly, total analgesic consumption through the first 24 hours postoperatively, and time of first analgesic request in the postoperative period
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 1 Feb 2023.
- 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.
Essam Ezzat, Professor study director
Professor of anesthesia, intensive care and pain management , formerly head of the department
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 paravertebral block and Transversus abdominis plane block in people with Postoperative Pain, 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 3 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 1 Feb 2023. 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?
comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block (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 1 Feb 2023.