Laparoscopic Cholecystectomy SurgeryMTAPA-EOINCT07595679
Comparison of M-TAPA and External Oblique Intercostal Block for Intraoperative Opioid Consumption in Laparoscopic Cholecystectomy
A study testing Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and External Oblique Intercostal Plane Block (EOI) in people with Laparoscopic Cholecystectomy Surgery and Perioperative Analgesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, interventional study compares the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery, Perioperative Analgesia
- What is being tested?
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and External Oblique Intercostal Plane Block (EOI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 1 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years
- ASA physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Ability to provide written informed consent
Who cannot join
- Patient refusal
- Known allergy to local anesthetics
- Chronic opioid use or opioid dependence
- Neurological or psychiatric disorders affecting pain perception
- Use of medications affecting autonomic nervous system activity, such as beta-blockers
- Infection at the injection site
- Coagulopathy or anticoagulant therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara etlik city hospital
Ankara, Yenimahalle
About this study
Official title: Comparison of M-TAPA and External Oblique Intercostal Plane Block on Intraoperative Analgesia and Opioid Consumption Guided by Skin Conductance Algesimeter in Laparoscopic Cholecystectomy
This prospective, randomized, interventional study compares the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy.
Eighty patients are randomized into two groups: the M-TAPA group and the EOI group. All patients receive standardized general anesthesia. Intraoperative analgesia is guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic nervous system activity by measuring fluctuations in skin conductance. The SCA parameter "peaks per second (PPS)" is used to assess nociceptive responses, and remifentanil infusion is titrated according to SCA values.
Read more
Patients assigned to the M-TAPA group receive bilateral ultrasound-guided M-TAPA block, while patients assigned to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side.
Perioperative analgesia is standardized. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the numeric rating scale (NRS) pain score is 4 or higher.
The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, intraoperative hemodynamic parameters, SCA measurements, postoperative pain scores, time to first rescue analgesic requirement, rescue analgesic consumption, postoperative nausea and vomiting, and perioperative complications.
The study aims to compare the opioid-sparing and analgesic effects of M-TAPA and EOI under objective nociception-guided intraoperative analgesia.
Read the detailed description
This prospective, randomized, interventional study compares modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) in patients undergoing elective laparoscopic cholecystectomy.
A total of 80 patients are randomized in a 1:1 ratio to either the M-TAPA group or the EOI group. Patients and postoperative outcome assessors are blinded to group allocation. The anesthesiologist performing the block is not blinded because of the nature of the procedures.
All patients receive standardized general anesthesia. Intraoperative analgesia is guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic activation through fluctuations in palmar skin conductance. The SCA-derived parameter "peaks per second (PPS)" is used as a real-time measure of nociceptive activity. Remifentanil is administered by continuous infusion and titrated according to SCA values to maintain the predefined target range.
Patients randomized to the M-TAPA group receive bilateral ultrasound-guided modified thoracoabdominal nerve block through perichondrial approach. Patients randomized to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side.
Intraoperative data include heart rate, mean arterial pressure, SCA-derived PPS values, and remifentanil infusion rates. The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, frequency of SCA values outside the predefined target range, postoperative pain intensity assessed using the numeric rating scale (NRS), time to first rescue analgesic requirement, rescue analgesic consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and perioperative complications.
Perioperative analgesia is standardized in both groups. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the NRS pain score is 4 or higher.
The study is designed to determine whether M-TAPA and EOI differ in their effects on intraoperative opioid requirements and postoperative analgesia when intraoperative nociception is objectively monitored using the Skin Conductance Algesimeter.
- Being tested
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA), External Oblique Intercostal Plane Block (EOI)
- Keywords
- M-TAPA, External Oblique Intercostal Block, Abdominal Wall Block, Skin Conductance Algesimeter, Remifentanil, Opioid Consumption, Laparoscopic Cholecystectomy, Intraoperative Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)Procedure or surgery
Also called M-TAPA
Patients received bilateral ultrasound-guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA). A total of 20 mL of 0.25% bupivacaine was administered on each side for perioperative analgesia during laparoscopic cholecystectomy.
External Oblique Intercostal Plane Block (EOI)Procedure or surgery
Also called EOI
Patients received bilateral ultrasound-guided external oblique intercostal plane block (EOI). A total of 20 mL of 0.25% bupivacaine was administered on each side for perioperative analgesia during laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA Group | Experimental | Patients assigned to this arm received bilateral modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for perioperative analgesia during laparoscopic cholecystectomy. Receives: Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) |
| EOI Group | Active comparator | Patients assigned to this arm received bilateral external oblique intercostal plane block (EOIPB) for perioperative analgesia during laparoscopic cholecystectomy. Receives: Procedure: External Oblique Intercostal Plane Block (EOI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
The time-weighted mean intraoperative remifentanil infusion rate will be calculated throughout the surgical period and expressed as micrograms per kilogram per minute (µg/kg/min) based on continuous infusion data.
Measured: Intraoperative period (from induction to end of surgery)
Secondary outcomes (7)
Postoperative Pain Scores Assessed by Numeric Rating Scale
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Assessments will be performed at rest and during movement.
Measured: 0, 2, 4, 6, 12, and 24 hours postoperatively
Time to First Analgesic Requirement
Time to First Analgesic Requirement
Measured: Within 24 hours postoperatively
Rescue Analgesic Consumption
Total amount of rescue analgesic (dexketoprofen) administered within the first 24 hours postoperatively.
Measured: First 24 hours postoperatively
Mean Arterial Pressure
Mean arterial pressure (MAP), expressed in mmHg, will be recorded intraoperatively and compared with baseline values.
Measured: Intraoperative period
Heart Rate
Heart rate, expressed as beats per minute, will be recorded intraoperatively and compared with baseline values.
Measured: Intraoperative period
Skin Conductance Algesimeter(SCA)
Skin Conductance Algesimeter (SCA) peaks per second (PPS) values recorded intraoperatively to assess nociceptive responses.
Measured: Intraoperative period
Postoperative Nausea and Vomiting (PONV)
Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.
Measured: First 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 posted19 May 2026
- Study start15 May 2026
- Primary completion31 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmet Uluhan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595679
- Sponsor's protocol ID
- AEŞH-EK-2026-019
- Acronym
- MTAPA-EOI
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in accordance with institutional policies
Publications
Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4.
PubMed 39891061Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
PubMed 34626112Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
PubMed 30639940
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of M-TAPA and External Oblique Intercostal Plane Block on Intraoperative Analgesia and Opioid Consumption Guided by Skin Conductance Algesimeter in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07595679
- Acronym / sponsor ID
- MTAPA-EOI / AEŞH-EK-2026-019
- Keywords
- M-TAPA, External Oblique Intercostal Block, Abdominal Wall Block, Skin Conductance Algesimeter, Remifentanil, Opioid Consumption, Laparoscopic Cholecystectomy, Intraoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 May 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 19 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, interventional study compares the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy.
Eighty patients are randomized into two groups: the M-TAPA group and the EOI group. All patients receive standardized general anesthesia. Intraoperative analgesia is guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic nervous system activity by measuring fluctuations in skin conductance. The SCA parameter "peaks per second (PPS)" is used to assess nociceptive responses, and remifentanil infusion is titrated according to SCA values.
Patients assigned to the M-TAPA group receive bilateral ultrasound-guided M-TAPA block, while patients assigned to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side.
Perioperative analgesia is standardized. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the numeric rating scale (NRS) pain score is 4 or higher.
The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, intraoperative hemodynamic parameters, SCA measurements, postoperative pain scores, time to first rescue analgesic requirement, rescue analgesic consumption, postoperative nausea and vomiting, and perioperative complications.
The study aims to compare the opioid-sparing and analgesic effects of M-TAPA and EOI under objective nociception-guided intraoperative analgesia.
Detailed description
This prospective, randomized, interventional study compares modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) in patients undergoing elective laparoscopic cholecystectomy.
A total of 80 patients are randomized in a 1:1 ratio to either the M-TAPA group or the EOI group. Patients and postoperative outcome assessors are blinded to group allocation. The anesthesiologist performing the block is not blinded because of the nature of the procedures.
All patients receive standardized general anesthesia. Intraoperative analgesia is guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic activation through fluctuations in palmar skin conductance. The SCA-derived parameter "peaks per second (PPS)" is used as a real-time measure of nociceptive activity. Remifentanil is administered by continuous infusion and titrated according to SCA values to maintain the predefined target range.
Patients randomized to the M-TAPA group receive bilateral ultrasound-guided modified thoracoabdominal nerve block through perichondrial approach. Patients randomized to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side.
Intraoperative data include heart rate, mean arterial pressure, SCA-derived PPS values, and remifentanil infusion rates. The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, frequency of SCA values outside the predefined target range, postoperative pain intensity assessed using the numeric rating scale (NRS), time to first rescue analgesic requirement, rescue analgesic consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and perioperative complications.
Perioperative analgesia is standardized in both groups. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the NRS pain score is 4 or higher.
The study is designed to determine whether M-TAPA and EOI differ in their effects on intraoperative opioid requirements and postoperative analgesia when intraoperative nociception is objectively monitored using the Skin Conductance Algesimeter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TAPA Group | Experimental | Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)Patients assigned to this arm received bilateral modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for perioperative analgesia during laparoscopic cholecystectomy. |
| EOI Group | Active comparator | Procedure: External Oblique Intercostal Plane Block (EOI)Patients assigned to this arm received bilateral external oblique intercostal plane block (EOIPB) for perioperative analgesia during laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-80 years
- ASA physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Patient refusal
- Known allergy to local anesthetics
- Chronic opioid use or opioid dependence
- Neurological or psychiatric disorders affecting pain perception
- Use of medications affecting autonomic nervous system activity, such as beta-blockers
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 |
|---|---|---|
| Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)Also: M-TAPAPatients received bilateral ultrasound-guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA). A total of 20 mL of 0.25% bupivacaine was administered on each side for perioperative analgesia during laparoscopic cholecystectomy. | Procedure or surgery | M-TAPA Group |
| External Oblique Intercostal Plane Block (EOI)Also: EOIPatients received bilateral ultrasound-guided external oblique intercostal plane block (EOI). A total of 20 mL of 0.25% bupivacaine was administered on each side for perioperative analgesia during laparoscopic cholecystectomy. | Procedure or surgery | EOI Group |
Primary outcome
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
Time frame: Intraoperative period (from induction to end of surgery)
The time-weighted mean intraoperative remifentanil infusion rate will be calculated throughout the surgical period and expressed as micrograms per kilogram per minute (µg/kg/min) based on continuous infusion data.
7 secondary outcomes
Postoperative Pain Scores Assessed by Numeric Rating Scale
Time frame: 0, 2, 4, 6, 12, and 24 hours postoperatively
Time to First Analgesic Requirement
Time frame: Within 24 hours postoperatively
Rescue Analgesic Consumption
Time frame: First 24 hours postoperatively
Mean Arterial Pressure
Time frame: Intraoperative period
Heart Rate
Time frame: Intraoperative period
Skin Conductance Algesimeter(SCA)
Time frame: Intraoperative period
Postoperative Nausea and Vomiting (PONV)
Time frame: First 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 23 Sep 2026.
- Background: PubMed 39891061Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4.
- Background: PubMed 34626112Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
- Background: PubMed 30639940Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in accordance with institutional policies
Related trials for Laparoscopic Cholecystectomy Surgery
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Not yet recruiting
Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
Cholelithiasis
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic
Not yet recruiting
Does the Transversus Abdominis Plane(TAP) Block Effectively Manage Pain After Laparoscopic Cholecystectomy?
TAP Block, Cholecystectomy, Laparoscopic
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 study testing Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and External Oblique Intercostal Plane Block (EOI) in people with Laparoscopic Cholecystectomy Surgery and Perioperative Analgesia, run by Ankara Etlik 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 8 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 23 Sep 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?
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?
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate (time frame: Intraoperative period (from induction to end of 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 NCT07595679, which also lists 3 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 23 Sep 2026.