Perioperative AnalgesiaNCT07276646
Perioperative Opioid-sparing Effect of Retrosuperior Costotransverse Ligament Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy
A study testing Retrosuperior costotransverse ligament block group and Erector spinae block group in people with Perioperative Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
This study aims to compare the analgesic effect of retro superior costotransverse ligament space block vs erector spinae plane block to Achieve high-quality perioperative opioid-sparing effect and postoperative analgesia after laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon… Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Analgesia
- What is being tested?
- Retrosuperior costotransverse ligament block group and Erector spinae block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2025to 10 Jul 2026
- 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient acceptance
- Age: 21-64 years old.
- Sex: both sexes.
- Physical status: ASA I \& II.
- Body mass index (BMI): 18.5 - 30 kg/m2.
- Type of operations: elective laparoscopic cholecystectomy.
- Duration of surgery not more than 2 hours.
Who cannot join
- Known hypersensitivity to lidocaine or bupivacaine.
- Patients with respiratory insufficiency.
- Coagulation disorders or taking drugs affect surgical hemostasis.
- 7. Patients with pre-existing neurological deficits. 8. Uncooperative patient or with altered mental status. 9. Patient with advanced cardiovascular or respiratory diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dina Salem, MD contact
Marwa Medhat, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of human medicine, Zagazig university, Zagazig
Zagazig
Dina Salem, MD, 01099333513 ext. 002, dinamaghraby@yahoo.com
About this study
Official title: Perioperative Opioid-sparing Effect of Retrosuperior Costotransverse Ligament Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy: A Randomized Clinical Trial.
This study aims to compare the analgesic effect of retro superior costotransverse ligament space block vs erector spinae plane block to Achieve high-quality perioperative opioid-sparing effect and postoperative analgesia after laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction
Read the detailed description
This study aims to compare between retro superior costotransverse ligament space block vs erector spinae plane block
- To compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption and pain scores by NRS)
- To assess the block performance time required to perform each technique .
- To compare intraoperative parameters (hemodynamics and intraoperative fentanyl consumption)
- To assess patient, surgeon satisfaction and complications of the block.
- Conditions
- Perioperative Analgesia
- Being tested
- Retrosuperior costotransverse ligament block group, Erector spinae block group
- Keywords
- retrosuperior costotransverse ligament block, erector spinae block, laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrosuperior costotransverse ligament block groupProcedure or surgery
The patient will receive retrosuperior costotransverse ligament block
Erector spinae block groupProcedure or surgery
The patient will receive erector spinae block.
| Study group | Role | What they receive |
|---|---|---|
| Retrosuperior costotransverse ligament block group | Active comparator | The patient will receive retrosuperior costotransverse ligament block Receives: Procedure: Retrosuperior costotransverse ligament block group |
| Erector spinae block group | Active comparator | The patient will receive erector spinae block. Receives: Procedure: Erector spinae block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first call to rescue analgesia
The time to first call to rescue analgesia( the interval between the block injection till the NRS more than or equal 4) (naluphine) will be recorded
Measured: 24 hours
Secondary outcomes (7)
To assess block characteristics (block performance time)
To assess block characteristics (block performance time) in minutes
Measured: 1 hour
Total intraoperative fentanyl consumption
Total intraoperative fentanyl required other than the induction dose in micrograms
Measured: duration of surgery (up to 2 hours)
Pain intensity by Numerical Rating Scale
Analgesic parameters (Pain intensity at rest and at movement) by using Numerical Rating Scale (NRS) which will explained to patient as follows:0=no pain and 10= worst pain
Measured: 30 minutes after arrival to post anesthesia care unit , 2hours, 4hours, 6hours, 8hours, 12hours, 18 hours and 24hours postoperative
total amount of rescue analgesia
total amount of rescue analgesia if NRS≥4. in the first 24 hours.
Measured: 24 hours
Intraoperative hemodynamics (Heart Rate and Mean Arterial Pressure)
Intraoperative hemodynamics every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery
Measured: every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery
Patient's satisfaction
all patient's satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
Measured: 24 hours
complication of the block
complication of the block( heamatoma,local anesthetic toxicity,infection)
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 posted11 Dec 2025
- Study start10 Dec 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Model description
- Achievement of high-quality perioperative opioid-sparing effect and postoperative analgesia for laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction by comparing retrosuperior costotransverse ligament block and erector spinae block in laparoscopic cholecystectomy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276646
- Sponsor's protocol ID
- 1783
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Opioid-sparing Effect of Retrosuperior Costotransverse Ligament Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07276646
- Acronym / sponsor ID
- 1783
- Conditions
- Perioperative Analgesia
- Keywords
- retrosuperior costotransverse ligament block, erector spinae block, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 11 Dec 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.
This study aims to compare the analgesic effect of retro superior costotransverse ligament space block vs erector spinae plane block to Achieve high-quality perioperative opioid-sparing effect and postoperative analgesia after laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction
Detailed description
This study aims to compare between retro superior costotransverse ligament space block vs erector spinae plane block
- To compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption and pain scores by NRS)
- To assess the block performance time required to perform each technique .
- To compare intraoperative parameters (hemodynamics and intraoperative fentanyl consumption)
- To assess patient, surgeon satisfaction and complications of the block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Achievement of high-quality perioperative opioid-sparing effect and postoperative analgesia for laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction by comparing retrosuperior costotransverse ligament block and erector spinae block in laparoscopic cholecystectomy
| Arm | Type | Receives |
|---|---|---|
| Retrosuperior costotransverse ligament block group | Active comparator | Procedure: Retrosuperior costotransverse ligament block groupThe patient will receive retrosuperior costotransverse ligament block |
| Erector spinae block group | Active comparator | Procedure: Erector spinae block groupThe patient will receive erector spinae block. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- patient acceptance
- Age: 21-64 years old.
- Sex: both sexes.
- Physical status: ASA I \& II.
- Body mass index (BMI): 18.5 - 30 kg/m2.
Key exclusion criteria (4 listed)
- Known hypersensitivity to lidocaine or bupivacaine.
- Patients with respiratory insufficiency.
- Coagulation disorders or taking drugs affect surgical hemostasis.
- 7. Patients with pre-existing neurological deficits. 8. Uncooperative patient or with altered mental status. 9. Patient with advanced cardiovascular or respiratory diseases
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 |
|---|---|---|
| Retrosuperior costotransverse ligament block groupThe patient will receive retrosuperior costotransverse ligament block | Procedure or surgery | Retrosuperior costotransverse ligament block group |
| Erector spinae block groupThe patient will receive erector spinae block. | Procedure or surgery | Erector spinae block group |
Primary outcome
The time to first call to rescue analgesia
Time frame: 24 hours
The time to first call to rescue analgesia( the interval between the block injection till the NRS more than or equal 4) (naluphine) will be recorded
7 secondary outcomes
To assess block characteristics (block performance time)
Time frame: 1 hour
Total intraoperative fentanyl consumption
Time frame: duration of surgery (up to 2 hours)
Pain intensity by Numerical Rating Scale
Time frame: 30 minutes after arrival to post anesthesia care unit , 2hours, 4hours, 6hours, 8hours, 12hours, 18 hours and 24hours postoperative
total amount of rescue analgesia
Time frame: 24 hours
Intraoperative hemodynamics (Heart Rate and Mean Arterial Pressure)
Time frame: every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery
Patient's satisfaction
Time frame: 24 hours
complication of the block
Time frame: 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 12 Dec 2025.
- 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.
Dina Salem, MD contact
Marwa Medhat, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrosuperior costotransverse ligament block group and Erector spinae block group in people with Perioperative Analgesia, run by Zagazig 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 7 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: looking for participants now, as of the sponsor's last update on 12 Dec 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 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 Dina Salem, MD (01099333513 ext. 002), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first call to rescue analgesia (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 12 Dec 2025.