Postoperative AnalgesiaPhase 3NCT07469410
Comparison of Postoperative Analgesia in Erector Spinae Plane Block (ESPB) v/s Subcostal Transversus Abdominal Plane Block (STAP) in Adults Undergoing Laparoscopic Cholecystectomy.
A Phase 3 study testing Landmark guided Erector Spinae Block and Landmark guided Transversus Abdominis Plane Block in people with Postoperative Analgesia, run by Patel Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Postoperative pain after laparoscopic cholecystectomy remains clinically relevant. This double-blinded randomized controlled trial compares the analgesic efficacy of landmark-guided Erector Spinae Plane Block (ESPB) and subcostal transversus abdominis plane (STAP) block in 60 adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Landmark guided Erector Spinae Block and Landmark guided Transversus Abdominis Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 15 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are both men and women.
- Patients aged 18 to 65.
- Patients are scheduled for a laparoscopic cholecystectomy.
- Patients with ASA Physical Status I or II. Finally, III.
- Give consent.
Who cannot join
- Hypersensitivity to local anesthesia.
- Infection at the block site.
- Coagulation disorders.
- BMI above 40kg/m2.
- Patients with pregnancy.
- Converted to open surgery.
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- Drain placement.
- Neurological or psychiatric disorders that impair cooperation.
- Patients are unwilling to cooperate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Postoperative Analgesia In Landmark Guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block In Laparoscopic Cholecystectomy; A Randomized Controlled Trial
Postoperative pain after laparoscopic cholecystectomy remains clinically relevant. This double-blinded randomized controlled trial compares the analgesic efficacy of landmark-guided Erector Spinae Plane Block (ESPB) and subcostal transversus abdominis plane (STAP) block in 60 adult patients. Postoperative pain will be evaluated using the Visual Analogue Scale at multiple time points, along with rescue analgesic requirements and time to first analgesic request, to assess the effectiveness of these techniques in resource-limited settings.
- Conditions
- Postoperative Analgesia
- Being tested
- Landmark guided Erector Spinae Block, Landmark guided Transversus Abdominis Plane Block
- Keywords
- ESPB, STAP, landmark-guided blocl, laparoscopic cholecystectomy, post operative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmark guided Erector Spinae BlockDrug
Patients will receive a landmark-guided Erector Spinae Plane Block on the right side at T9 level with 30 mL of 0.25% ropivacaine after induction of general anesthesia.
Landmark guided Transversus Abdominis Plane BlockDrug
Patients will receive a landmark-guided Subcostal Transversus Abdominis Plane Block on the right side with 30 mL of 0.25% ropivacaine after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Landmark-guided Erector Spinae Plane Block | Experimental | Patients will receive a landmark-guided erector spinae plane block on the right side at the T9 level with 30 mL of 0.25% ropivacaine after induction of general anesthesia. Receives: Drug: Landmark guided Erector Spinae Block |
| landmark-guided Subcostal Transversus Abdominis Plane Block | Active comparator | Patients will receive a landmark-guided Subcostal Transversus Abdominis Plane Block on the right side with 30 mL of 0.25% ropivacaine after induction of general anesthesia. Receives: Drug: Landmark guided Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
Measured: From arrival in the post-anesthesia care unit (PACU) through 24 hours postoperatively, assessed at 30 minutes in PACU, and at 6 hours, 12 hours, and 24 hours after surgery.
Secondary outcomes (1)
need for rescue analgesia and time for first analgesic request.
Proportion of patients requiring rescue analgesia during the postoperative period.
Measured: From completion of surgery through 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jun 2025
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kulsoom Mehmood, Patel Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469410
- Sponsor's protocol ID
- PH/IRB/2025/023
- Other IDs
- PH/IRB/2025/023
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vadera HK, Mistry T. Erector spinae plane block: Anatomical landmark-guided technique. Saudi J Anaesth. 2019 Jul-Sep;13(3):268-269. doi: 10.4103/sja.SJA_780_18. No abstract available.
PubMed 31333385Dey S, Mistry T, Mittapalli J, Neema PK. Landmark guided continuous erector spinae plane block: An adjunct for perioperative analgesia in a patient with difficult back operated for total hip arthroplasty. Saudi J Anaesth. 2020 Apr-Jun;14(2):276-277. doi: 10.4103/sja.SJA_46_20. Epub 2020 Mar 5. No abstract available.
PubMed 32317901Saadawi M, Layera S, Aliste J, Bravo D, Leurcharusmee P, Tran Q. Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks. J Clin Anesth. 2021 Feb;68:110063. doi: 10.1016/j.jclinane.2020.110063. Epub 2020 Oct 5.
PubMed 33032124Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
PubMed 30886130Ozdemir H, Araz C, Karaca O, Turk E. Comparison of Ultrasound-Guided Erector Spinae Plane Block and Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia after Laparoscopic Cholecystectomy: A Randomized, Controlled Trial. J Invest Surg. 2022 Apr;35(4):870-877. doi: 10.1080/08941939.2021.1931574. Epub 2021 Jun 4.
PubMed 34085883Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.
PubMed 30851501Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
PubMed 35550031Chin KJ, Pawa A, Forero M, Adhikary S. Ultrasound-Guided Fascial Plane Blocks of the Thorax: Pectoral I and II, Serratus Anterior Plane, and Erector Spinae Plane Blocks. Adv Anesth. 2019 Dec;37:187-205. doi: 10.1016/j.aan.2019.08.007. Epub 2019 Sep 13. No abstract available.
PubMed 31677656Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Ramkiran S, Jacob M, Honwad M, Vivekanand D, Krishnakumar M, Patrikar S. Ultrasound-guided Combined Fascial Plane Blocks as an Intervention for Pain Management after Laparoscopic Cholecystectomy: A Randomized Control Study. Anesth Essays Res. 2018 Jan-Mar;12(1):16-23. doi: 10.4103/aer.AER_157_17.
PubMed 29628547Canitez A, Kozanhan B, Aksoy N, Yildiz M, Tutar MS. Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study. Br J Anaesth. 2021 Oct;127(4):629-635. doi: 10.1016/j.bja.2021.06.030. Epub 2021 Jul 31.
PubMed 34340839
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Postoperative Analgesia In Landmark Guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block In Laparoscopic Cholecystectomy; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07469410
- Acronym / sponsor ID
- PH/IRB/2025/023
- Conditions
- Postoperative Analgesia
- Keywords
- ESPB, STAP, landmark-guided blocl, laparoscopic cholecystectomy, post operative analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Patel Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 13 Mar 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.
Postoperative pain after laparoscopic cholecystectomy remains clinically relevant. This double-blinded randomized controlled trial compares the analgesic efficacy of landmark-guided Erector Spinae Plane Block (ESPB) and subcostal transversus abdominis plane (STAP) block in 60 adult patients. Postoperative pain will be evaluated using the Visual Analogue Scale at multiple time points, along with rescue analgesic requirements and time to first analgesic request, to assess the effectiveness of these techniques in resource-limited settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Landmark-guided Erector Spinae Plane Block | Experimental | Drug: Landmark guided Erector Spinae BlockPatients will receive a landmark-guided erector spinae plane block on the right side at the T9 level with 30 mL of 0.25% ropivacaine after induction of general anesthesia. |
| landmark-guided Subcostal Transversus Abdominis Plane Block | Active comparator | Drug: Landmark guided Transversus Abdominis Plane BlockPatients will receive a landmark-guided Subcostal Transversus Abdominis Plane Block on the right side with 30 mL of 0.25% ropivacaine after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are both men and women.
- Patients aged 18 to 65.
- Patients are scheduled for a laparoscopic cholecystectomy.
- Patients with ASA Physical Status I or II. Finally, III.
- Give consent.
Key exclusion criteria (9 listed)
- Hypersensitivity to local anesthesia.
- Infection at the block site.
- Coagulation disorders.
- BMI above 40kg/m2.
- Patients with pregnancy.
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 |
|---|---|---|
| Landmark guided Erector Spinae BlockPatients will receive a landmark-guided Erector Spinae Plane Block on the right side at T9 level with 30 mL of 0.25% ropivacaine after induction of general anesthesia. | Drug | Experimental: Landmark-guided Erector Spinae Plane Block |
| Landmark guided Transversus Abdominis Plane BlockPatients will receive a landmark-guided Subcostal Transversus Abdominis Plane Block on the right side with 30 mL of 0.25% ropivacaine after induction of general anesthesia. | Drug | landmark-guided Subcostal Transversus Abdominis Plane Block |
Primary outcome
VAS score
Time frame: From arrival in the post-anesthesia care unit (PACU) through 24 hours postoperatively, assessed at 30 minutes in PACU, and at 6 hours, 12 hours, and 24 hours after surgery.
Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
1 secondary outcome
need for rescue analgesia and time for first analgesic request.
Time frame: From completion of surgery through 24 hours postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 31333385Vadera HK, Mistry T. Erector spinae plane block: Anatomical landmark-guided technique. Saudi J Anaesth. 2019 Jul-Sep;13(3):268-269. doi: 10.4103/sja.SJA_780_18. No abstract available.
- Background: PubMed 32317901Dey S, Mistry T, Mittapalli J, Neema PK. Landmark guided continuous erector spinae plane block: An adjunct for perioperative analgesia in a patient with difficult back operated for total hip arthroplasty. Saudi J Anaesth. 2020 Apr-Jun;14(2):276-277. doi: 10.4103/sja.SJA_46_20. Epub 2020 Mar 5. No abstract available.
- Background: PubMed 33032124Saadawi M, Layera S, Aliste J, Bravo D, Leurcharusmee P, Tran Q. Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks. J Clin Anesth. 2021 Feb;68:110063. doi: 10.1016/j.jclinane.2020.110063. Epub 2020 Oct 5.
- Background: PubMed 30886130Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
- Background: PubMed 34085883Ozdemir H, Araz C, Karaca O, Turk E. Comparison of Ultrasound-Guided Erector Spinae Plane Block and Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia after Laparoscopic Cholecystectomy: A Randomized, Controlled Trial. J Invest Surg. 2022 Apr;35(4):870-877. doi: 10.1080/08941939.2021.1931574. Epub 2021 Jun 4.
- Background: PubMed 30851501Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.
- Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- Background: PubMed 35550031Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
- Background: PubMed 31677656Chin KJ, Pawa A, Forero M, Adhikary S. Ultrasound-Guided Fascial Plane Blocks of the Thorax: Pectoral I and II, Serratus Anterior Plane, and Erector Spinae Plane Blocks. Adv Anesth. 2019 Dec;37:187-205. doi: 10.1016/j.aan.2019.08.007. Epub 2019 Sep 13. No abstract available.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 29628547Ramkiran S, Jacob M, Honwad M, Vivekanand D, Krishnakumar M, Patrikar S. Ultrasound-guided Combined Fascial Plane Blocks as an Intervention for Pain Management after Laparoscopic Cholecystectomy: A Randomized Control Study. Anesth Essays Res. 2018 Jan-Mar;12(1):16-23. doi: 10.4103/aer.AER_157_17.
- Background: PubMed 34340839Canitez A, Kozanhan B, Aksoy N, Yildiz M, Tutar MS. Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study. Br J Anaesth. 2021 Oct;127(4):629-635. doi: 10.1016/j.bja.2021.06.030. Epub 2021 Jul 31.
- 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 3 study testing Landmark guided Erector Spinae Block and Landmark guided Transversus Abdominis Plane Block in people with Postoperative Analgesia, run by Patel Hospital, Pakistan at 1 site in Pakistan.
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 9 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: finished, as of the sponsor's last update on 13 Mar 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 Pakistan. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS score (time frame: From arrival in the post-anesthesia care unit (PACU) through 24 hours postoperatively, assessed at 30 minutes in PACU, and at 6 hours, 12 hours, and 24 hours after surgery.). 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 NCT07469410, which also lists 12 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 13 Mar 2026.