Postoperative PainNCT07403682
M-TAPA vs ESPB for Postoperative Analgesia After Laparoscopic Cholecystectomy
A study testing Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA) and erector spinae plane block (ESPB) in people with Postoperative Pain and Cholecystectomy, Laparoscopic, run by Başakşehir Çam & Sakura City Hospital at 3 sites in Turkey (Türkiye).
Trial summary
Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Cholecystectomy, Laparoscopic
- What is being tested?
- Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA) 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
- 130 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 3 Mar 2026to 23 May 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Refusal to participate
- Known allergy to local anesthetics
- Coagulation disorders or anticoagulant therapy
- Infection at the injection site
- Severe hepatic, renal, or cardiac disease
- Chronic opioid use
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Başakşehir Çam and Sakura City Hospital
Istanbul
Istanbul Medipol University Hospital
Istanbul
Karabük University
Karabük, Karabük Province
About this study
Official title: Comparison of M-TAPA and ESPB Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects.
The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited.
This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.
Read the detailed description
This study is designed as a prospective, randomized, single-blind controlled clinical trial conducted in adult patients scheduled for elective laparoscopic cholecystectomy. The primary objective of the study is to compare the postoperative analgesic effectiveness of the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB).
Eligible patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly assigned in a 1:1 ratio to receive either M-TAPA or ESPB. Randomization will be performed using a computer-generated random number sequence, and allocation will be concealed in sealed, opaque envelopes to prevent selection bias.
All blocks will be performed under ultrasound guidance by experienced anesthesiologists using standard local anesthetic agents routinely applied in clinical practice. The study is designed as single-blind, with patients blinded to group allocation.
Postoperative pain intensity was assessed using the numerical rating scale (NRS) at rest and during movement at PACU admission and at 3, 6, 12, 18, and 24 hours postoperatively. Additional outcome measures include total opioid consumption within the first 24 postoperative hours, time to first analgesic requirement, need for rescue analgesia, and patient satisfaction. Adverse events related to regional anesthesia techniques will be recorded.
The study follows the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the relevant Clinical Research Ethics Committee prior to study initiation.
- Conditions
- Postoperative Pain, Cholecystectomy, Laparoscopic
- Being tested
- Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA), erector spinae plane block (ESPB)
- Keywords
- Laparoscopic cholecystectomy, M-TAPA block, Erector spinae plane block (ESPB), Regional anesthesia, Postoperative analgesia, Opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA)Procedure or surgery
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
erector spinae plane block (ESPB)Procedure or surgery
An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA Block | Experimental | An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy. Receives: Procedure: Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA) |
| ESPB | Experimental | An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy. Receives: Procedure: erector spinae plane block (ESPB) |
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
Total cumulative opioid consumption within the first 24 hours after surgery, recorded as intravenous tramadol equivalent dose.
Measured: within the first 24 hours postoperatively
Secondary outcomes (7)
Pain intensity at rest (NRS)
Postoperative pain intensity at rest assessed using the Numerical Rating Scale (NRS).
Measured: PACU, 3, 6, 12, 18, and 24 hours postoperatively
Pain intensity during movement (NRS)
Postoperative pain intensity during movement assessed using the Numerical Rating Scale (NRS).
Measured: PACU, 3, 6, 12, 18, and 24 hours postoperatively
Rescue analgesic requirement
Number of patients requiring rescue analgesic medication.
Measured: Within the first 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Incidence of postoperative nausea and vomiting assessed by a blinded observer using a five-point verbal descriptive scale
Measured: At postoperative hours 0, 6, 12, and 24
Time to first rescue analgesia
Time from the end of surgery to the first administration of rescue analgesic medication.
Measured: Within the first 24 hours postoperatively
Quality of recovery (QoR-15)
Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
Measured: Postoperative 24 hours
Patient satisfaction
Patient satisfaction with postoperative analgesia assessed using a 10-point numerical rating scale.
Measured: Postoperative 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 Feb 2026
- Study start3 Mar 2026
- Primary completion23 May 2026
- Study completion23 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403682
- Sponsor's protocol ID
- BCS-MTAPA-01
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of M-TAPA and ESPB Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07403682
- Acronym / sponsor ID
- BCS-MTAPA-01
- Conditions
- Postoperative Pain, Cholecystectomy, Laparoscopic
- Keywords
- Laparoscopic cholecystectomy, M-TAPA block, Erector spinae plane block (ESPB), Regional anesthesia, Postoperative analgesia, Opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 23 May 2026 (actual)
- First posted
- 11 Feb 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 can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects.
The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited.
This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.
Detailed description
This study is designed as a prospective, randomized, single-blind controlled clinical trial conducted in adult patients scheduled for elective laparoscopic cholecystectomy. The primary objective of the study is to compare the postoperative analgesic effectiveness of the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB).
Eligible patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly assigned in a 1:1 ratio to receive either M-TAPA or ESPB. Randomization will be performed using a computer-generated random number sequence, and allocation will be concealed in sealed, opaque envelopes to prevent selection bias.
All blocks will be performed under ultrasound guidance by experienced anesthesiologists using standard local anesthetic agents routinely applied in clinical practice. The study is designed as single-blind, with patients blinded to group allocation.
Postoperative pain intensity was assessed using the numerical rating scale (NRS) at rest and during movement at PACU admission and at 3, 6, 12, 18, and 24 hours postoperatively. Additional outcome measures include total opioid consumption within the first 24 postoperative hours, time to first analgesic requirement, need for rescue analgesia, and patient satisfaction. Adverse events related to regional anesthesia techniques will be recorded.
The study follows the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the relevant Clinical Research Ethics Committee prior to study initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TAPA Block | Experimental | Procedure: Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA)An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy. |
| ESPB | Experimental | Procedure: erector spinae plane block (ESPB)An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18-65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (6 listed)
- Refusal to participate
- Known allergy to local anesthetics
- Coagulation disorders or anticoagulant therapy
- Infection at the injection site
- Severe hepatic, renal, or cardiac disease
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 |
|---|---|---|
| Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA)An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy. | Procedure or surgery | M-TAPA Block |
| erector spinae plane block (ESPB)An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy. | Procedure or surgery | ESPB |
Primary outcome
Total Opioid Consumption in the First 24 Hours
Time frame: within the first 24 hours postoperatively
Total cumulative opioid consumption within the first 24 hours after surgery, recorded as intravenous tramadol equivalent dose.
7 secondary outcomes
Pain intensity at rest (NRS)
Time frame: PACU, 3, 6, 12, 18, and 24 hours postoperatively
Pain intensity during movement (NRS)
Time frame: PACU, 3, 6, 12, 18, and 24 hours postoperatively
Rescue analgesic requirement
Time frame: Within the first 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Time frame: At postoperative hours 0, 6, 12, and 24
Time to first rescue analgesia
Time frame: Within the first 24 hours postoperatively
Quality of recovery (QoR-15)
Time frame: Postoperative 24 hours
Patient satisfaction
Time frame: Postoperative 24 hours
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 27 Oct 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA) and erector spinae plane block (ESPB) in people with Postoperative Pain and Cholecystectomy, Laparoscopic, run by Başakşehir Çam & Sakura City Hospital at 3 sites 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 6 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Total Opioid Consumption in the First 24 Hours (time frame: within the first 24 hours postoperatively). 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 27 Oct 2026.