Laparoscopic Cholecystectomy Surgery Postoperative AnalgesiaNCT07598162
RLB vs ERSP for Postoperative Analgesia in Lap Cholecystectomy
A study testing Retrolaminar Block (RLB) and Erector spinae plane block (ESPB) in people with Laparoscopic Cholecystectomy Surgery Postoperative Analgesia, run by Sohag University at 1 site in Egypt.
Trial summary
This prospective, randomized, double-blind clinical trial evaluates the comparative effectiveness of ultrasound-guided retrolaminar block (RLB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery Postoperative Analgesia
- What is being tested?
- Retrolaminar Block (RLB) and Erector spinae plane block (ESPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to 1 Sep 2027
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Age from 20 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) grade I and II physical status.
- Patients will undergo cholecystectomy under general anesthesia.
Who cannot join
- • Sensitivities or contraindications to the study medications.
- Infection at the site of injection.
- Emergency surgery.
- Body mass index (BMI) > 35.
- Organic comorbidities.
- Histories of psychological conditions and/or chronic pain syndromes.
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- Contraindications to regional anesthesia.
- Severe respiratory, cardiac, hepatic and renal disorders.
- Pregnancy.
- Coagulopathy.
- Opioid addiction.
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
Sohag Faculty of Medicine
Sohag
Esraa abdallah Mohamed, resident, 01066981675, esraa97egy@gmail.com
About this study
Official title: Retrolaminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Comparative Randomized Prospective Study
This prospective, randomized, double-blind clinical trial evaluates the comparative effectiveness of ultrasound-guided retrolaminar block (RLB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. A total of 100 ASA I-II patients, aged 20-60 years, will be randomly allocated into two equal groups to receive either RLB or ESPB bilaterally following induction of standardized general anesthesia. The primary outcome is the time to first request for rescue analgesia, while secondary outcomes include total morphine consumption within the first 24 hours, postoperative pain scores assessed using the Numeric Rating Scale (NRS), patient satisfaction, and the incidence of adverse events. Pain assessment will be performed at predefined intervals over the first 24 hours postoperatively. The study aims to determine which technique provides superior analgesia with reduced opioid requirements and improved patient outcomes.
- Being tested
- Retrolaminar Block (RLB), Erector spinae plane block (ESPB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar Block (RLB)Biological
Patients will be positioned laterally, and a curved ultrasound probe will be aligned longitudinally at the T7 vertebra. The vertebral lamina and spinous process will be identified. A needle will be inserted 1 - 1.5 cm lateral to the spinous process, advanced toward the lamina, and 20 mL of LA mixture will be injected into the fascial plane between the lamina and transversus spinae muscles bilaterally.
Erector spinae plane block (ESPB)Procedure or surgery
The blocks will be conducted at the level of the T7 spinous process (SP) with the patient in the lateral position and the arm abducted. Using US ( curved probe ) , the T7 transverse process (TP) is identified by counting from the 12th rib. The US probe is positioned 2 - 3 cm laterally to the SP of T7 and situated over the TP of T7/T8 in the parasagittal longitudinal plane, with the erector spinae muscle (ESM) visualized over the TP. The needle is then inserted and advanced in plane from cephalad to caudad until the needle tip contacts the TP of T7. Following hydro dissection with 2 mL of isotonic saline, which elevates the ESM, 20 mL of LA mixture is administered after several negative aspirations.
| Study group | Role | What they receive |
|---|---|---|
| RLB group | Active comparator | Not described Receives: Biological: Retrolaminar Block (RLB) |
| ESPB group | Active comparator | Not described Receives: Procedure: Erector spinae plane block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
Measured: in the 1st 24hr.
Secondary outcomes (3)
Total morphine consumption
Measured: in the 1st 24hr.
Pain score.
postoperative pain assessment with the Numeric Rating Scale (NRS). Numeric rating scale .. zero represents no pain while 10 represents the worst pain imaginable
Measured: Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.
Degree of patient satisfaction
- Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1 represents extremely dissatisfied 2 represesnts unsatisfied; 3 represents neutral 4 represents satisfied 5 represents extremely satisfied)
Measured: in the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy Surgery Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdallah Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598162
- Sponsor's protocol ID
- soh-Med-26-3-9MS
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrolaminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Comparative Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07598162
- Acronym / sponsor ID
- soh-Med-26-3-9MS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 May 2026 (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 prospective, randomized, double-blind clinical trial evaluates the comparative effectiveness of ultrasound-guided retrolaminar block (RLB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. A total of 100 ASA I-II patients, aged 20-60 years, will be randomly allocated into two equal groups to receive either RLB or ESPB bilaterally following induction of standardized general anesthesia. The primary outcome is the time to first request for rescue analgesia, while secondary outcomes include total morphine consumption within the first 24 hours, postoperative pain scores assessed using the Numeric Rating Scale (NRS), patient satisfaction, and the incidence of adverse events. Pain assessment will be performed at predefined intervals over the first 24 hours postoperatively. The study aims to determine which technique provides superior analgesia with reduced opioid requirements and improved patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLB group | Active comparator | Biological: Retrolaminar Block (RLB) |
| ESPB group | Active comparator | Procedure: Erector spinae plane block (ESPB) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Age from 20 to 60 years.
Key exclusion criteria (11 listed)
- • Sensitivities or contraindications to the study medications.
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 |
|---|---|---|
| Retrolaminar Block (RLB)Patients will be positioned laterally, and a curved ultrasound probe will be aligned longitudinally at the T7 vertebra. The vertebral lamina and spinous process will be identified. A needle will be inserted 1 - 1.5 cm lateral to the spinous process, advanced toward the lamina, and 20 mL of LA mixture will be injected into the fascial plane between the lamina and transversus spinae muscles bilaterally. | Biological | RLB group |
| Erector spinae plane block (ESPB)The blocks will be conducted at the level of the T7 spinous process (SP) with the patient in the lateral position and the arm abducted. Using US ( curved probe ) , the T7 transverse process (TP) is identified by counting from the 12th rib. The US probe is positioned 2 - 3 cm laterally to the SP of T7 and situated over the TP of T7/T8 in the parasagittal longitudinal plane, with the erector spinae muscle (ESM) visualized over the TP. The needle is then inserted and advanced in plane from cephalad to caudad until the needle tip contacts the TP of T7. Following hydro dissection with 2 mL of isotonic saline, which elevates the ESM, 20 mL of LA mixture is administered after several negative aspirations. | Procedure or surgery | ESPB group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: in the 1st 24hr.
3 secondary outcomes
Total morphine consumption
Time frame: in the 1st 24hr.
Pain score.
Time frame: Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.
Degree of patient satisfaction
Time frame: in the first 24 hours after surgery
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 20 May 2026.
- 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 Retrolaminar Block (RLB) and Erector spinae plane block (ESPB) in people with Laparoscopic Cholecystectomy Surgery Postoperative Analgesia, run by Sohag 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 4 inclusion and 11 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 20 May 2026. 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 Esraa abdallah Mohamed, resident (01066981675, esraa97egy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the 1st rescue analgesia (time frame: in the 1st 24hr.). 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 20 May 2026.