Opioid UseTAPNCT05946733
Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy
A study testing Group A, Group B and Group C in people with Opioid Use, run by Menoufia University at 1 site in Egypt.
Trial summary
the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Group A, Group B and Group C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2022to 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 patients will be older than 21 years old with American society of anaesthesia physical status I\& II scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- - Uncooperative.
- Patients who have allergy to any of the study drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
- Local infection at the site of injection or systemic infection.
- Pregnancy.
- Patients with coagulation disorders or on anticoagulation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between The Analgesic Effect of Oblique Subcostal and Lateral Approach of Ultrasound-Guided Transverse Abdominis Blocks for Patients Undergoing Laparoscopic Cholecystectomy
the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy
Read the detailed description
General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane
During anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.
Patients will be randomly divided into three equal groups:
Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA).
- Conditions
- Opioid Use
- Being tested
- Group A, Group B, Group C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AProcedure or surgery
After induction of general anesthesia, oblique subcostal TAP blocks will be done(14) under the guidance of Sonosite ,superficial probe ,14-15 MHz ultrasound transducer
Group BProcedure or surgery
After induction of general anesthesia, bilateral lateral TAP block will be performed (15) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz)
Group COther
the analgesia will be maintained using a morphine patient-controlled analgesia (PCA) device set to give 1.5 mg bolus administration of morphine without a basic rate and 15 min lock-out time. The total amount of morphine administration will be recorded for the subsequent 24 h
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | subcostal TAP block Receives: Procedure: Group A |
| Group B | Experimental | lateral TAP block. Receives: Procedure: Group B |
| GroupC | Other | will receive postoperative morphine by patient-controlled analgesia (PCA). Receives: Other: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
milligrams
Measured: 48 hours
Secondary outcomes (4)
patient satisfaction
visual analogue scale ((a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)
Measured: 48 hours
anesthesia recovery time
minutes
Measured: 1hour
total perioperative analgesics requirements
milligrams
Measured: 24 hours
Post-operative anaesthetic care unit (PACU) stay
minutes
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start26 Nov 2022
- Primary completion10 Aug 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 Opioid UseStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly divided into three equal groups using SPSS. Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. GroupC:will receive postoperative morphine by patient-controlled analgesia (PCA).
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- AMAL G SAFAN, MD, Study director, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946733
- Sponsor's protocol ID
- 11/2022ANET10-26
- Acronym
- TAP
- Status last verified
- Jan 2024
- First submitted
- 17 Jun 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Comparison Between The Analgesic Effect of Oblique Subcostal and Lateral Approach of Ultrasound-Guided Transverse Abdominis Blocks for Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05946733
- Acronym / sponsor ID
- TAP / 11/2022ANET10-26
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 14 Jul 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.
the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy
Detailed description
General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane
During anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.
Patients will be randomly divided into three equal groups:
Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomly divided into three equal groups using SPSS. Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. GroupC:will receive postoperative morphine by patient-controlled analgesia (PCA).
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Group Asubcostal TAP block |
| Group B | Experimental | Procedure: Group Blateral TAP block. |
| GroupC | Other | Other: Group Cwill receive postoperative morphine by patient-controlled analgesia (PCA). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be older than 21 years old with American society of anaesthesia physical status I\& II scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (7 listed)
- - Uncooperative.
- Patients who have allergy to any of the study drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
- 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 |
|---|---|---|
| Group AAfter induction of general anesthesia, oblique subcostal TAP blocks will be done(14) under the guidance of Sonosite ,superficial probe ,14-15 MHz ultrasound transducer | Procedure or surgery | Group A |
| Group BAfter induction of general anesthesia, bilateral lateral TAP block will be performed (15) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz) | Procedure or surgery | Group B |
| Group Cthe analgesia will be maintained using a morphine patient-controlled analgesia (PCA) device set to give 1.5 mg bolus administration of morphine without a basic rate and 15 min lock-out time. The total amount of morphine administration will be recorded for the subsequent 24 h | Other | GroupC |
Primary outcome
opioid consumption
Time frame: 48 hours
milligrams
4 secondary outcomes
patient satisfaction
Time frame: 48 hours
anesthesia recovery time
Time frame: 1hour
total perioperative analgesics requirements
Time frame: 24 hours
Post-operative anaesthetic care unit (PACU) stay
Time frame: 2 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 26 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.
AMAL G SAFAN, MD study director
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 Group A, Group B and Group C in people with Opioid Use, run by Menoufia 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 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?
opioid consumption (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.