Transversus Abdominis Plane BlockNCT06707324
Analgesic Efficacy of Transversus Abdominis Plane Block Versus External Oblique Block in Patients Undergoing Elective Laparoscopic Cholecystectomy
A study testing drug injected between the rectus abdominis muscle and the transversus abdominis muscle and drug injected in the external oblique intercostal plane on both sides in people with Transversus Abdominis Plane Block and External Oblique Block, run by Assiut University at 1 site in Egypt.
Trial summary
Postoperative pain management is a critical aspect of recovery following laparoscopic cholecystectomy, a commonly performed procedure for symptomatic gallbladder disease. Effective analgesia not only enhances patient comfort but also facilitates early mobilization, reduces the incidence of complications, and improves… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transversus Abdominis Plane Block, External Oblique Block, Laparoscopic Cholecystectomy
- What is being tested?
- drug injected between the rectus abdominis muscle and the transversus abdominis muscle and drug injected in the external oblique intercostal plane on both sides
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-60 years.
- Gender: Both males and females.
- BMI less than 35 kg/m2
- Scheduled for laparoscopic cholecystectomy surgery
- American Society of Anesthesiologists - ASA - I \& II
Who cannot join
- 1-ASA physical status more than II. 2-History of allergic response to local anaesthetics or any of the medications used in the study
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of medicine, Assiut University, Assiut, Egypt,
Asyut, 71515
Ghada Abo Elfadl, 01005802086, ghadafadl77@gmail.com
About this study
Postoperative pain management is a critical aspect of recovery following laparoscopic cholecystectomy, a commonly performed procedure for symptomatic gallbladder disease. Effective analgesia not only enhances patient comfort but also facilitates early mobilization, reduces the incidence of complications, and improves overall outcomes.
Oblique subcostal transversus abdominis plane block (OSTAP), one of the regional anesthesia techniques, is used in middle and upper abdominal surgeries OSTAP blocks the T6-9 intercostal nerves between the rectus abdominis and transversus abdominis muscle. Many studies have shown that OSTAP block reduces the postoperative analgesic and opioid requirement and improves the quality of postoperative pain control.
Read the detailed description
the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia.
Various adjuvants have been used to improve the quality and increase the duration of the local anesthetic action in different peripheral nerves and regional block techniques. dexamethasone microspheres have increased the block duration in both human and animal studies. Furthermore, dexamethasone has been shown to possess antiinflamatory action.
- Being tested
- drug injected between the rectus abdominis muscle and the transversus abdominis muscle, drug injected in the external oblique intercostal plane on both sides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug injected between the rectus abdominis muscle and the transversus abdominis muscleProcedure or surgery
20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides
drug injected in the external oblique intercostal plane on both sidesProcedure or surgery
20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides
| Study group | Role | What they receive |
|---|---|---|
| TAB group | Active comparator | 20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides Receives: Procedure: drug injected between the rectus abdominis muscle and the transversus abdominis muscle |
| EOB group | Active comparator | 20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides Receives: Procedure: drug injected in the external oblique intercostal plane on both sides |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first analgesic request depending on Numeric Rating Scale
the first analgesic request depending on Numeric Rating Scale
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transversus Abdominis Plane BlockStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707324
- Sponsor's protocol ID
- 04-2024-201012
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
PubMed 34626112Wang W, Wang L, Gao Y. A Meta-Analysis of Randomized Controlled Trials Concerning the Efficacy of Transversus Abdominis Plane Block for Pain Control After Laparoscopic Cholecystectomy. Front Surg. 2021 Aug 4;8:700318. doi: 10.3389/fsurg.2021.700318. eCollection 2021.
PubMed 34422893
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Transversus Abdominis Plane Block Versus External Oblique Block in Patients Undergoing Elective Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06707324
- Acronym / sponsor ID
- 04-2024-201012
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 27 Nov 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.
Postoperative pain management is a critical aspect of recovery following laparoscopic cholecystectomy, a commonly performed procedure for symptomatic gallbladder disease. Effective analgesia not only enhances patient comfort but also facilitates early mobilization, reduces the incidence of complications, and improves overall outcomes.
Oblique subcostal transversus abdominis plane block (OSTAP), one of the regional anesthesia techniques, is used in middle and upper abdominal surgeries OSTAP blocks the T6-9 intercostal nerves between the rectus abdominis and transversus abdominis muscle. Many studies have shown that OSTAP block reduces the postoperative analgesic and opioid requirement and improves the quality of postoperative pain control.
Detailed description
the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia.
Various adjuvants have been used to improve the quality and increase the duration of the local anesthetic action in different peripheral nerves and regional block techniques. dexamethasone microspheres have increased the block duration in both human and animal studies. Furthermore, dexamethasone has been shown to possess antiinflamatory action.
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 |
|---|---|---|
| TAB group | Active comparator | Procedure: drug injected between the rectus abdominis muscle and the transversus abdominis muscle20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides |
| EOB group | Active comparator | Procedure: drug injected in the external oblique intercostal plane on both sides20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients aged 18-60 years.
- Gender: Both males and females.
- BMI less than 35 kg/m2
- Scheduled for laparoscopic cholecystectomy surgery
- American Society of Anesthesiologists - ASA - I \& II
Key exclusion criteria (2 listed)
- 1-ASA physical status more than II. 2-History of allergic response to local anaesthetics or any of the medications used 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 |
|---|---|---|
| drug injected between the rectus abdominis muscle and the transversus abdominis muscle20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides | Procedure or surgery | TAB group |
| drug injected in the external oblique intercostal plane on both sides20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides | Procedure or surgery | EOB group |
Primary outcome
the first analgesic request depending on Numeric Rating Scale
Time frame: 24hours
the first analgesic request depending on Numeric Rating Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Results publication: PubMed 34626112Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
- Results publication: PubMed 34422893Wang W, Wang L, Gao Y. A Meta-Analysis of Randomized Controlled Trials Concerning the Efficacy of Transversus Abdominis Plane Block for Pain Control After Laparoscopic Cholecystectomy. Front Surg. 2021 Aug 4;8:700318. doi: 10.3389/fsurg.2021.700318. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug injected between the rectus abdominis muscle and the transversus abdominis muscle and drug injected in the external oblique intercostal plane on both sides in people with Transversus Abdominis Plane Block and External Oblique Block, 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada Ghada Abo Elfadl, Asossciated professor (ghadafadl77@gmail.com, ghadafadl77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first analgesic request depending on Numeric Rating Scale (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707324, which also lists 2 linked publications.
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 3 Dec 2024.