Cholelithiasis, Postoperative Pain, Laparoscopic CholecystectomyESP TAPNCT07661693
ESP vs Subcostal TAP Block for Analgesia After Laparoscopic Cholecystectomy
A study testing Erector Spinae Plane Block and Subcostal Transversus Abdominis Plane Block in people with Cholelithiasis, Postoperative Pain, Laparoscopic Cholecystectomy, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind study compares the analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The primary outcome is 24-hour postoperative opioid consumption. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholelithiasis, Postoperative Pain, Laparoscopic Cholecystectomy
- What is being tested?
- Erector Spinae Plane Block and Subcostal Transversus Abdominis Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2027to 15 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study protocol and provide written informed consent -
Who cannot join
- Known allergy or contraindication to local anesthetic agents
- Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
- Infection at the planned injection site
- Body mass index (BMI) > 35 kg/m²
- Chronic opioid use or opioid dependence
- Chronic pain syndromes requiring regular analgesic treatment
Show all 10Show fewer
- Severe hepatic, renal, or cardiac dysfunction
- Pregnancy or breastfeeding
- Inability to communicate or assess pain using the Numerical Rating Scale (NRS)
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziantep City Hospital
Şahinbey, Gaziantep, 27060
About this study
Official title: Comparison Of Ultrasound-guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block For Postoperative Analgesia In Laparoscopic Cholecystectomy: A Prospective Randomized Double-blind Multicenter Trial
This prospective, randomized, double-blind study compares the analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The primary outcome is 24-hour postoperative opioid consumption. Secondary outcomes include postoperative pain scores, time to first analgesic request, shoulder pain, postoperative nausea and vomiting, and block-related complications.
Read the detailed description
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements.
The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation.
This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers.
The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications.
Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan.
The findings of this study are expected to provide evidence-based guidance for optimizing regional analgesia strategies in laparoscopic cholecystectomy.
- Being tested
- Erector Spinae Plane Block, Subcostal Transversus Abdominis Plane Block
- Keywords
- ESP Block, TAP Block, Regional Anesthesia, Ultrasound, Laparoscopic Cholecystectomy, Postoperative Analgesia, Opioid Use
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia. The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle. The procedure will be performed by experienced anesthesiologists under sterile conditions.
Subcostal Transversus Abdominis Plane BlockProcedure or surgery
Ultrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia. A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin. The procedure will be performed by experienced anesthesiologists under sterile conditions.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Patients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia. Receives: Procedure: Erector Spinae Plane Block |
| Subcostal TAP Block | Experimental | Patients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia. Receives: Procedure: Subcostal Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption in the First 24 Hours Postoperatively
Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.
Measured: Within 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 posted22 Jun 2026
- Study start15 Jun 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholelithiasis, Postoperative Pain, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, randomized, double-blind, parallel-group clinical trial. Eligible patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned in a 1:1 ratio to receive either bilateral erector spinae plane block or bilateral subcostal transversus abdominis plane block. Randomization will be performed using a computer-generated sequence with allocation concealment. Patients and postoperative outcome assessors will be blinded to group assignment. Standardized intraoperative anesthesia and postoperative multimodal analgesia protocols will be applied in both groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekir Suat Kürkçüoğlu, Gaziantep City Hospital
- Investigators
- Bekir Suat Kürkçüoğlu, Principal investigator, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661693
- Sponsor's protocol ID
- BS-ESP-TAP-2026
- Acronym
- ESP TAP
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
This study will generate individual participant data (IPD) related to postoperative analgesia, including opioid consumption, pain scores, and block-related complications. Data will be de-identified prior to sharing. Access to IPD will be available upon reasonable request to the corresponding author after publication of the main study results. Data requests will require a signed data use agreement, specifying the purpose of analysis and acknowledgment of original investigators. Supporting documentation, including study protocol and statistical analysis plan, will also be provided to researchers granted access.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Ultrasound-guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block For Postoperative Analgesia In Laparoscopic Cholecystectomy: A Prospective Randomized Double-blind Multicenter Trial
- ClinicalTrials.gov ID
- NCT07661693
- Acronym / sponsor ID
- ESP TAP / BS-ESP-TAP-2026
- Keywords
- ESP Block, TAP Block, Regional Anesthesia, Ultrasound, Laparoscopic Cholecystectomy, Postoperative Analgesia, Opioid Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 15 Jun 2027 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 22 Jun 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 study compares the analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The primary outcome is 24-hour postoperative opioid consumption. Secondary outcomes include postoperative pain scores, time to first analgesic request, shoulder pain, postoperative nausea and vomiting, and block-related complications.
Detailed description
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements.
The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation.
This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers.
The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications.
Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan.
The findings of this study are expected to provide evidence-based guidance for optimizing regional analgesia strategies in laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, randomized, double-blind, parallel-group clinical trial. Eligible patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned in a 1:1 ratio to receive either bilateral erector spinae plane block or bilateral subcostal transversus abdominis plane block. Randomization will be performed using a computer-generated sequence with allocation concealment. Patients and postoperative outcome assessors will be blinded to group assignment. Standardized intraoperative anesthesia and postoperative multimodal analgesia protocols will be applied in both groups.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockPatients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia. |
| Subcostal TAP Block | Experimental | Procedure: Subcostal Transversus Abdominis Plane BlockPatients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study protocol and provide written informed consent -
Key exclusion criteria (10 listed)
- Known allergy or contraindication to local anesthetic agents
- Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
- Infection at the planned injection site
- Body mass index (BMI) > 35 kg/m²
- Chronic opioid use or opioid dependence
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 |
|---|---|---|
| Erector Spinae Plane BlockUltrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia. The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle. The procedure will be performed by experienced anesthesiologists under sterile conditions. | Procedure or surgery | Erector Spinae Plane Block |
| Subcostal Transversus Abdominis Plane BlockUltrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia. A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin. The procedure will be performed by experienced anesthesiologists under sterile conditions. | Procedure or surgery | Subcostal TAP Block |
Primary outcome
Total Opioid Consumption in the First 24 Hours Postoperatively
Time frame: Within 24 hours after surgery
Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.
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 22 Jun 2026.
- BackgroundThis study will generate individual participant data (IPD) related to postoperative analgesia, including opioid consumption, pain scores, and block-related complications. Data will be de-identified prior to sharing. Access to IPD will be available upon reasonable request to the corresponding author after publication of the main study results. Data requests will require a signed data use agreement, specifying the purpose of analysis and acknowledgment of original investigators. Supporting documentation, including study protocol and statistical analysis plan, will also be provided to researchers granted access.
- 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.
Bekir Suat Kürkçüoğlu principal investigator
Gaziantep City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Subcostal Transversus Abdominis Plane Block in people with Cholelithiasis, Postoperative Pain, Laparoscopic Cholecystectomy, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
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 10 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 22 Jun 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 Turkey (Türkiye). 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 Bekir Suat Kürkçüoğlu (05055830463, bekirsuat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption in the First 24 Hours Postoperatively (time frame: Within 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 NCT07661693, which also lists 1 linked publication.
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 22 Jun 2026.