Laparoscopic CholecystectomyPhase 1NCT07182110
Dexamethasone-Enhanced TAP Block in Lapchole
A Phase 1 study testing Dexamethasone enhanced TAP Block and Marcaine- 0.25% in people with Laparoscopic Cholecystectomy, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
The transversus abdominis plane (TAP) block is widely used as part of analgesia for abdominal surgeries such as laparoscopic cholecystectomy. While bupivacaine is commonly used for TAP blocks with reported success. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Dexamethasone enhanced TAP Block and Marcaine- 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 19 Aug 2025to 30 Aug 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Patients
- Laparoscopic Cholecystectomy Patients
- Patients able to consent
Who cannot join
- Patients allergic to dexamethasone
- Allergic to Marcaine
- Hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexamethasone-Enhanced TAP Block Mixture on Postoperative Analgesia in Laparoscopic Cholecystectomy
The transversus abdominis plane (TAP) block is widely used as part of analgesia for abdominal surgeries such as laparoscopic cholecystectomy. While bupivacaine is commonly used for TAP blocks with reported success. Dexamethasone is often used as an adjuvant in prolonging duration of blocks; however, data on its efficacy in enhancing TAP blocks in laparoscopic cholecystectomy remain limited. This study aims to assess whether adding dexamethasone to bupivacaine in a TAP block improves postoperative pain control and reduces opioid consumption
Read the detailed description
Hypothesis Patients receiving a dexamethasone-enhanced TAP block will have a longer duration of analgesia, lower postoperative pain scores, and reduced opioid requirements compared to patients receiving local anesthetic alone.
Objectives
- Primary Objective:
- To evaluate the time to first postoperative analgesic request.
- Secondary Objectives:
- To assess postoperative pain using the Visual Analog Scale (VAS).
- To evaluate the incidence of postoperative nausea and vomiting (PONV).
- To compare total postoperative analgesic consumption.
- To assess the need for rescue analgesia.
Methods Study Design
- Prospective, randomized, double-blind clinical trial. Study Population
- Adult patients (age ≥18), ASA physical status I to III, planned for elective laparoscopic cholecystectomy. Interventions
- All patients will undergo standard general anesthesia.
- TAP block will be performed pre-induction bilaterally by an experienced anesthesiologist blinded to the injectate.
- Patients will be randomized into two groups:
- Group A (Control): 20 ml solution containing 0.25% bupivacaine + normal saline
- Group B (Intervention): 20 ml solution containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline
All patients will receive standard postoperative care, including paracetamol and antiemetics
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Dexamethasone enhanced TAP Block, Marcaine- 0.25%
- Keywords
- Transversus Abdominis, Nerve Block, Dexamethasone, Pain, Acute Pain, Pain Management, Breakthrough Pain, Analgesics, Opioid, Anesthesia
- Medical subject headings
- Pain, Acute Pain, Agnosia, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone enhanced TAP BlockDrug
20 ml Marcaine containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline
Marcaine- 0.25%Drug
20 ml solution containing 0.25% bupivacaine + normal saline
| Study group | Role | What they receive |
|---|---|---|
| Marcaine | Active comparator | Not described Receives: Drug: Marcaine- 0.25% |
| Marcaine and Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone enhanced TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic requirement (in hours)
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start19 Aug 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad-Ali Barada, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182110
- Sponsor's protocol ID
- MGH-07-25037
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghani SA, Hussain HU, Wahid MA, Majeed N, Burney S, Tanveer A, Asghar MS. Laparoscopic-assisted versus ultrasound-guided transversus abdominis plane block for laparoscopic cholecystectomy: a systematic review and meta-analysis. BMC Surg. 2024 Dec 21;24(1):400. doi: 10.1186/s12893-024-02706-7.
PubMed 39709396Uzunay NT, Mingir T, Erginoz E, Karakas DO, Kose E. Comparison of laparoscopic-guided versus ultrasound-guided TAP block in laparoscopic cholecystectomy. Cir Cir. 2024;92(2):174-180. doi: 10.24875/CIRU.23000394.
PubMed 38782390Taheri P, Moinfar Z, Varpaei HA. Comparison of the Stress Responses After TAP Block and Epidural Anesthesia in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia: Randomized Clinical Trial. Clin J Pain. 2023 Jul 1;39(7):319-325. doi: 10.1097/AJP.0000000000001117.
PubMed 37083674Nair P, Behera CR, Patra RK, Shekar N, Rao LS, Pujari P, Panda B, Mishra A. Efficacy and Cost-Effectiveness of Laparoscopic Transversus Abdominis Plane (TAP) Block in Laparoscopic Cholecystectomy: A Comparison With the Non-TAP Group. Cureus. 2022 Nov 30;14(11):e32038. doi: 10.7759/cureus.32038. eCollection 2022 Nov.
PubMed 36600856
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone-Enhanced TAP Block Mixture on Postoperative Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07182110
- Acronym / sponsor ID
- MGH-07-25037
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Transversus Abdominis, Nerve Block, Dexamethasone, Pain, Acute Pain, Pain Management, Breakthrough Pain, Analgesics, Opioid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Sep 2025 (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 transversus abdominis plane (TAP) block is widely used as part of analgesia for abdominal surgeries such as laparoscopic cholecystectomy. While bupivacaine is commonly used for TAP blocks with reported success. Dexamethasone is often used as an adjuvant in prolonging duration of blocks; however, data on its efficacy in enhancing TAP blocks in laparoscopic cholecystectomy remain limited. This study aims to assess whether adding dexamethasone to bupivacaine in a TAP block improves postoperative pain control and reduces opioid consumption
Detailed description
Hypothesis Patients receiving a dexamethasone-enhanced TAP block will have a longer duration of analgesia, lower postoperative pain scores, and reduced opioid requirements compared to patients receiving local anesthetic alone.
Objectives
- Primary Objective:
- To evaluate the time to first postoperative analgesic request.
- Secondary Objectives:
- To assess postoperative pain using the Visual Analog Scale (VAS).
- To evaluate the incidence of postoperative nausea and vomiting (PONV).
- To compare total postoperative analgesic consumption.
- To assess the need for rescue analgesia.
Methods Study Design
- Prospective, randomized, double-blind clinical trial. Study Population
- Adult patients (age ≥18), ASA physical status I to III, planned for elective laparoscopic cholecystectomy. Interventions
- All patients will undergo standard general anesthesia.
- TAP block will be performed pre-induction bilaterally by an experienced anesthesiologist blinded to the injectate.
- Patients will be randomized into two groups:
- Group A (Control): 20 ml solution containing 0.25% bupivacaine + normal saline
- Group B (Intervention): 20 ml solution containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline
All patients will receive standard postoperative care, including paracetamol and antiemetics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marcaine | Active comparator | Drug: Marcaine- 0.25% |
| Marcaine and Dexamethasone | Experimental | Drug: Dexamethasone enhanced TAP Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patients
- Laparoscopic Cholecystectomy Patients
- Patients able to consent
Key exclusion criteria (3 listed)
- Patients allergic to dexamethasone
- Allergic to Marcaine
- Hemodynamically unstable
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 |
|---|---|---|
| Dexamethasone enhanced TAP Block20 ml Marcaine containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline | Drug | Marcaine and Dexamethasone |
| Marcaine- 0.25%20 ml solution containing 0.25% bupivacaine + normal saline | Drug | Marcaine |
Primary outcome
Time to first analgesic requirement (in hours)
Time frame: within 24 hours
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 19 Sep 2025.
- Results publication: PubMed 39709396Ghani SA, Hussain HU, Wahid MA, Majeed N, Burney S, Tanveer A, Asghar MS. Laparoscopic-assisted versus ultrasound-guided transversus abdominis plane block for laparoscopic cholecystectomy: a systematic review and meta-analysis. BMC Surg. 2024 Dec 21;24(1):400. doi: 10.1186/s12893-024-02706-7.
- Results publication: PubMed 38782390Uzunay NT, Mingir T, Erginoz E, Karakas DO, Kose E. Comparison of laparoscopic-guided versus ultrasound-guided TAP block in laparoscopic cholecystectomy. Cir Cir. 2024;92(2):174-180. doi: 10.24875/CIRU.23000394.
- Results publication: PubMed 37083674Taheri P, Moinfar Z, Varpaei HA. Comparison of the Stress Responses After TAP Block and Epidural Anesthesia in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia: Randomized Clinical Trial. Clin J Pain. 2023 Jul 1;39(7):319-325. doi: 10.1097/AJP.0000000000001117.
- Results publication: PubMed 36600856Nair P, Behera CR, Patra RK, Shekar N, Rao LS, Pujari P, Panda B, Mishra A. Efficacy and Cost-Effectiveness of Laparoscopic Transversus Abdominis Plane (TAP) Block in Laparoscopic Cholecystectomy: A Comparison With the Non-TAP Group. Cureus. 2022 Nov 30;14(11):e32038. doi: 10.7759/cureus.32038. eCollection 2022 Nov.
- 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 Phase 1 study testing Dexamethasone enhanced TAP Block and Marcaine- 0.25% in people with Laparoscopic Cholecystectomy, run by Makassed General Hospital at 1 site in Lebanon.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. 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 Lebanon. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Time to first analgesic requirement (in hours) (time frame: within 24 hours). 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 NCT07182110, which also lists 4 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 19 Sep 2025.