AnalgesiaU/STAPNCT06224179
Role of Ultrasound Guided Transversus Abdominis Plane Block in Pain Control After Hepatectomy
A study testing ultrasound guided subcostal TAP block and ultrasound guided combined posterior and subcostal TAP block in people with Analgesia, run by Ain Shams University.
Trial summary
Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound guided subcostal TAP block and ultrasound guided combined posterior and subcostal TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Jun 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.
Who cannot join
- patients under 18 years of age.
- History of Allergic reactions to study drugs.
- Opioid or analgesic abuse, and chronic treatment with opioids, or non-steroidal anti-inflammatory drugs.
- History of bleeding tendency or coagulopathy .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Oblique Subcostal Transversus Abdominis Plane Block(TAP) Versus Both Subcostal and Posterior TAP Block as Postoperative Analgesia in Hepatectomy
Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. These consequences encompass patient distress, respiratory complications, delirium, myocardial ischemia, extended hospital stays, an elevated risk of chronic pain, heightened analgesic consumption, delayed bowel function, and an increased need for rescue analgesics.
This study aims to assess the postoperative analgesic efficacy of ultrasound-guided Transversus Abdominis Plane (TAP) block using oblique subcostal and posterior approaches in hepatectomy.
Read the detailed description
Pain control is vital to achieve enhanced recovery after abdominal surgeries . TAP block had been demonstrated to improve pain related outcomes after abdominal surgeries.
Postoperative pain management for patients undergoing hepatic resection is a challenge due to the risk of perioperative liver dysfunction.TAP block is a promising regional analgesic technique. This study aimed to evaluate the effect of US-guided subcostal approach versus combination of both subcostal and posterior approaches of TAP block
The patients will be randomly divided into two groups :
group A will recieve oblique subcostal TAP block and group B will recieve both subcostal and posterior TAP block .
- Conditions
- Analgesia
- Being tested
- ultrasound guided subcostal TAP block, ultrasound guided combined posterior and subcostal TAP block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided subcostal TAP blockProcedure or surgery
patients will be randomly divided into two groups using a computer generated random number chart.
Group A received ultrasound guided subcostal TAP block,
ultrasound guided combined posterior and subcostal TAP blockProcedure or surgery
patients will be randomly divided into two groups using a computer generated random number chart.
Group B received ultrasound guided combined posterior and subcostal TAP block,
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received ultrasound guided subcostal TAP block with 30 ml of local anesthetics and additives Receives: Procedure: ultrasound guided subcostal TAP block |
| Group B | Experimental | Group B received ultrasound guided both subcostal and posterior TAP block with 30 ml of local anesthetics and additives at each side Receives: Procedure: ultrasound guided combined posterior and subcostal TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia (VAS) during the 1st 24 hours in ICU
Pain will be assessed on admission and at 2, 4, 8, 12 and 24 hours at rest and with passive flexion of hip and knee joint using visual analogue scale (VAS) ranging from 0 for no pain to 10 for worst pain.
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 posted25 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed wagih Ezzat deusouky, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224179
- Sponsor's protocol ID
- M S 96/2021
- Acronym
- U/STAP
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Oblique Subcostal Transversus Abdominis Plane Block(TAP) Versus Both Subcostal and Posterior TAP Block as Postoperative Analgesia in Hepatectomy
- ClinicalTrials.gov ID
- NCT06224179
- Acronym / sponsor ID
- U/STAP / M S 96/2021
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. These consequences encompass patient distress, respiratory complications, delirium, myocardial ischemia, extended hospital stays, an elevated risk of chronic pain, heightened analgesic consumption, delayed bowel function, and an increased need for rescue analgesics.
This study aims to assess the postoperative analgesic efficacy of ultrasound-guided Transversus Abdominis Plane (TAP) block using oblique subcostal and posterior approaches in hepatectomy.
Detailed description
Pain control is vital to achieve enhanced recovery after abdominal surgeries . TAP block had been demonstrated to improve pain related outcomes after abdominal surgeries.
Postoperative pain management for patients undergoing hepatic resection is a challenge due to the risk of perioperative liver dysfunction.TAP block is a promising regional analgesic technique. This study aimed to evaluate the effect of US-guided subcostal approach versus combination of both subcostal and posterior approaches of TAP block
The patients will be randomly divided into two groups :
group A will recieve oblique subcostal TAP block and group B will recieve both subcostal and posterior TAP block .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: ultrasound guided subcostal TAP blockGroup A received ultrasound guided subcostal TAP block with 30 ml of local anesthetics and additives |
| Group B | Experimental | Procedure: ultrasound guided combined posterior and subcostal TAP blockGroup B received ultrasound guided both subcostal and posterior TAP block with 30 ml of local anesthetics and additives at each side |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.
Key exclusion criteria (4 listed)
- patients under 18 years of age.
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 |
|---|---|---|
| ultrasound guided subcostal TAP blockpatients will be randomly divided into two groups using a computer generated random number chart. Group A received ultrasound guided subcostal TAP block, | Procedure or surgery | Group A |
| ultrasound guided combined posterior and subcostal TAP blockpatients will be randomly divided into two groups using a computer generated random number chart. Group B received ultrasound guided combined posterior and subcostal TAP block, | Procedure or surgery | Group B |
Primary outcome
postoperative analgesia (VAS) during the 1st 24 hours in ICU
Time frame: 24 hours
Pain will be assessed on admission and at 2, 4, 8, 12 and 24 hours at rest and with passive flexion of hip and knee joint using visual analogue scale (VAS) ranging from 0 for no pain to 10 for worst pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided subcostal TAP block and ultrasound guided combined posterior and subcostal TAP block in people with Analgesia, run by Ain Shams University.
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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El-Dolah, lecturer of Anesthesia (+20111113077, a_wagih82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative analgesia (VAS) during the 1st 24 hours in ICU (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 30 Jan 2024.