Laparoscopic CholecystectomyPhase 3NCT07027540
Unilateral Right-Sided Erector Spinae Plane Block for Analgesia in Laparoscopic Cholecystectomy: Does the Volume Matter? A Randomized Controlled Trial
A Phase 3 study testing Bupivacaine 0.25% 20ml, 2mg of dexamethasone and 35 ml of Bupivacaine 0.25% in people with Laparoscopic Cholecystectomy, run by Assiut University.
Trial summary
Laparoscopic cholecystectomy is one of the most common surgeries today, cause it has many advantages over open cholecystectomy. (1) Although these advantages pain remains a big problem after laparoscopic cholecystectomy which causes patient admission or readmission. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Bupivacaine 0.25% 20ml, 2mg of dexamethasone and 35 ml of Bupivacaine 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Sep 2026
- Phase
- Phase 3
- 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 within age; (18-60)
- Body mass index (BMI); (18-30)
- ASA I - II
Who cannot join
- Patient refusal to participate in the study Allergy to local anesthetics Coagulopathy Morbid obesity Decreased pulmonary reserve Cardiac disorder Renal dysfunction Pre-existing neurological deficit Psychiatric illness
About this study
Laparoscopic cholecystectomy is one of the most common surgeries today, cause it has many advantages over open cholecystectomy. (1) Although these advantages pain remains a big problem after laparoscopic cholecystectomy which causes patient admission or readmission. (2) This post-operative laparoscopic cholecystectomy pain causes extreme patient discomfort, extended post-anesthesia care unit stay, and restricts early recovery. (3) To overcome this problem, there were trials of inta abdominal instillation with local anesthetics with no positive results (4,5), so they combined this with local infiltration at the laparoscopic access sites (6,7) with no satisfactory postoperative analgesia. (6,8,9).
With more attention to regional anesthesia as part of multimodal analgesia, different techniques have been used for post-LC pain control, such as paravertebral block (10), rectus sheath block (11), transversus abdominis plane block (12), intercostal nerve block (13), subcostal transversus abdominal plane block (STAP), thoracic epidural, and erector spinae plane block.
Read more
Erector spinae plane block which was first described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for the prevention of postoperative pain in various surgeries. (14) Case reports and randomized control trials have shown the efficacy of bilateral ESPB for pain control after LC , though the effects of Unilateral ESPB have not been extensively studied yet. A trial by Poupak Rahimzadeh et al, concluded that a single-shot, right-sided, unilateral ESPB with 20 ml volume LA decreases post-LC opioid consumption and pain The exact mechanism of action of the erector spinae plane (ESP) block remains unclear. Schwartzmann et al. used MRI to investigate this and identified three main mechanisms: spread to the paravertebral space through the intertransverse soft tissue, circumferential epidural spread via the intervertebral foramina, and intercostal spread (15).
The circumferential spread of local anesthetic into the epidural space opens the question of the possibility of contralateral spread, which was discussed by Tulgar et al, a case study that found bilateral sensory block caused by a unilateral ESPB with 30 ml volume of local anesthetic (16).
Based on these findings, we hypothesize that increasing the volume of local anesthetic may enhance the efficacy of the block by promoting wider spread, potentially resulting in improved analgesia and even bilateral sensory blockade following a unilateral injection.
This study aims to answer the question: Can unilateral ESPB with high volume result in superior analgesia for LC and perhaps bilateral block The primary outcome is the numeric rating scale (NRS) score at 12h postoperative
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Bupivacaine 0.25% 20ml, 2mg of dexamethasone, 35 ml of Bupivacaine 0.25%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% 20mlDrug
Adult patients will take a total 20 ml of Bupivacaine 0.25%
2mg of dexamethasoneDrug
2mg of dexamethasone in the right T7
35 ml of Bupivacaine 0.25%Drug
Adult patients will take a total 35 ml of Bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Adult patients will take a total 35 ml of Bupivacaine 0.25% and 2mg of Dexmethasone in the right T7. Receives: Drug: 2mg of dexamethasone; Drug: 35 ml of Bupivacaine 0.25% |
| Group B | Active comparator | Adult patients will take a total 20 ml of Bupivacaine 0.25% and 2mg of dexamethasone in the right T7. Receives: Drug: Bupivacaine 0.25% 20ml; Drug: 2mg of dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score after 12 hours in the 2 groups.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eithar Mahmoud Abd-Elsalm, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027540
- Sponsor's protocol ID
- uni Rt ESPB LAB Cholecystectom
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Right-Sided Erector Spinae Plane Block for Analgesia in Laparoscopic Cholecystectomy: Does the Volume Matter? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07027540
- Acronym / sponsor ID
- uni Rt ESPB LAB Cholecystectom
- Conditions
- Laparoscopic Cholecystectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Jun 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.
Laparoscopic cholecystectomy is one of the most common surgeries today, cause it has many advantages over open cholecystectomy. (1) Although these advantages pain remains a big problem after laparoscopic cholecystectomy which causes patient admission or readmission. (2) This post-operative laparoscopic cholecystectomy pain causes extreme patient discomfort, extended post-anesthesia care unit stay, and restricts early recovery. (3) To overcome this problem, there were trials of inta abdominal instillation with local anesthetics with no positive results (4,5), so they combined this with local infiltration at the laparoscopic access sites (6,7) with no satisfactory postoperative analgesia. (6,8,9).
With more attention to regional anesthesia as part of multimodal analgesia, different techniques have been used for post-LC pain control, such as paravertebral block (10), rectus sheath block (11), transversus abdominis plane block (12), intercostal nerve block (13), subcostal transversus abdominal plane block (STAP), thoracic epidural, and erector spinae plane block.
Erector spinae plane block which was first described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for the prevention of postoperative pain in various surgeries. (14) Case reports and randomized control trials have shown the efficacy of bilateral ESPB for pain control after LC , though the effects of Unilateral ESPB have not been extensively studied yet. A trial by Poupak Rahimzadeh et al, concluded that a single-shot, right-sided, unilateral ESPB with 20 ml volume LA decreases post-LC opioid consumption and pain The exact mechanism of action of the erector spinae plane (ESP) block remains unclear. Schwartzmann et al. used MRI to investigate this and identified three main mechanisms: spread to the paravertebral space through the intertransverse soft tissue, circumferential epidural spread via the intervertebral foramina, and intercostal spread (15).
The circumferential spread of local anesthetic into the epidural space opens the question of the possibility of contralateral spread, which was discussed by Tulgar et al, a case study that found bilateral sensory block caused by a unilateral ESPB with 30 ml volume of local anesthetic (16).
Based on these findings, we hypothesize that increasing the volume of local anesthetic may enhance the efficacy of the block by promoting wider spread, potentially resulting in improved analgesia and even bilateral sensory blockade following a unilateral injection.
This study aims to answer the question: Can unilateral ESPB with high volume result in superior analgesia for LC and perhaps bilateral block The primary outcome is the numeric rating scale (NRS) score at 12h postoperative
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: 2mg of dexamethasone, Drug: 35 ml of Bupivacaine 0.25%Adult patients will take a total 35 ml of Bupivacaine 0.25% and 2mg of Dexmethasone in the right T7. |
| Group B | Active comparator | Drug: Bupivacaine 0.25% 20ml, Drug: 2mg of dexamethasoneAdult patients will take a total 20 ml of Bupivacaine 0.25% and 2mg of dexamethasone in the right T7. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients within age; (18-60)
- Body mass index (BMI); (18-30)
- ASA I - II
Key exclusion criteria (1 listed)
- Patient refusal to participate in the study Allergy to local anesthetics Coagulopathy Morbid obesity Decreased pulmonary reserve Cardiac disorder Renal dysfunction Pre-existing neurological deficit Psychiatric illness
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 |
|---|---|---|
| Bupivacaine 0.25% 20mlAdult patients will take a total 20 ml of Bupivacaine 0.25% | Drug | Group B |
| 2mg of dexamethasone2mg of dexamethasone in the right T7 | Drug | Group A, Group B |
| 35 ml of Bupivacaine 0.25%Adult patients will take a total 35 ml of Bupivacaine 0.25% | Drug | Group A |
Primary outcome
NRS score after 12 hours in the 2 groups.
Time frame: 12 hours
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable
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 18 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine 0.25% 20ml, 2mg of dexamethasone and 35 ml of Bupivacaine 0.25% in people with Laparoscopic Cholecystectomy, run by Assiut 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 3 inclusion and 1 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 18 Jun 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
NRS score after 12 hours in the 2 groups. (time frame: 12 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 18 Jun 2025.