Postoperative PainNCT07751770
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study
A study testing Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach and Bilateral Ultrasound-Guided Erector Spinae Plane Block in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy
- What is being tested?
- Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach and Bilateral Ultrasound-Guided Erector Spinae Plane Block
- 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
- 20 Feb 2025to 2 Dec 2025
- 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
- Age between 18 and 65 years
- Scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologists physical status I to III
- Body mass index below 35 kg/m²
- International Normalized Ratio and platelet count within the institutional reference ranges
- Liver and renal function test results within the institutional reference ranges
- Provision of written informed consent
Who cannot join
- Bleeding diathesis
- Known allergy to local anesthetics
- Infection or inflammation at the planned block application site
- Gallbladder perforation
- Known neurological disease
- American Society of Anesthesiologists physical status IV or higher
Show all 13Show fewer
- Long-term medication use for chronic pain
- Advanced liver or renal failure
- Previous abdominal surgery or abdominal trauma
- Use of any opioid medication within 24 hours before surgery
- Pregnancy
- Refusal to participate
- Intraoperative conversion from laparoscopic to open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Directorate of Health Sultan 2.Abdul Hamid Khan Educational and Research Hospital
Istanbul, 34000
About this study
This study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block.
Adults undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly assigned to receive one of these two nerve blocks on both sides of the body before awakening from anesthesia. Both techniques used bupivacaine as the local anesthetic.
After surgery, pain intensity, tramadol consumption, need for additional pain medication, nausea and vomiting, antiemetic use, and block-related complications were assessed during the first 24 postoperative hours. The main objective was to determine whether the two techniques differed in their ability to reduce postoperative tramadol consumption and provide effective pain relief.
Read the detailed description
This was a prospective, single-center, randomized, parallel-group controlled study conducted in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Eligible participants were 18 to 65 years of age and had an American Society of Anesthesiologists physical status classification of I to III.
After providing written informed consent, participants were randomly assigned using a sealed-envelope method to one of two study groups. Participants in the first group received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. Participants in the second group received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. Both blocks were performed with 0.25% bupivacaine after removal of the gallbladder and before extubation.
General anesthesia and perioperative multimodal analgesia were standardized for both groups. Following surgery, all participants received intravenous patient-controlled analgesia with tramadol. Additional paracetamol was administered when the Visual Analog Scale pain score was 4 or higher. Ondansetron was administered when postoperative nausea or vomiting was present.
The primary outcome was cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes included Visual Analog Scale pain scores, patient-controlled analgesia demand, tramadol consumption at individual assessment times, additional analgesic requirement, postoperative nausea and vomiting, antiemetic requirement, and block-related complications. Outcomes were assessed upon arrival in the post-anesthesia care unit and at 30 minutes and 2, 3, 6, and 24 hours after surgery.
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Being tested
- Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach, Bilateral Ultrasound-Guided Erector Spinae Plane Block
- Keywords
- Postoperative Analgesia, Modified Thoracoabdominal Nerve Block Through Perichondrial Approach, M-TAPA Block, Erector Spinae Plane Block, Ultrasound-Guided Regional Anesthesia, Tramadol Consumption, Acute Postoperative Pain, Patient-Controlled Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial ApproachProcedure or surgery
After removal of the gallbladder and before extubation, the block was performed bilaterally under ultrasound guidance. The external oblique, internal oblique, and transversus abdominis muscles were identified at the inferior margin of the 10th costal cartilage. A block needle was advanced using an in-plane technique toward the inferior surface of the costal cartilage. After confirmation of the needle position with 2 to 3 mL of normal saline, 20 mL of 0.25% bupivacaine was administered on each side.
Bilateral Ultrasound-Guided Erector Spinae Plane BlockProcedure or surgery
After removal of the gallbladder and before extubation, the block was performed bilaterally under ultrasound guidance at the T7 vertebral level. The needle was advanced using an in-plane technique until its tip was positioned between the erector spinae muscle and the transverse process. After confirmation of the needle position with 2 to 3 mL of normal saline, 20 mL of 0.25% bupivacaine was administered on each side.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Modified Thoracoabdominal Nerve Block Through Perichondrial Approach | Experimental | After removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. The block was performed at the inferior surface of the 10th costal cartilage using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms. Receives: Procedure: Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach |
| Bilateral Erector Spinae Plane Block | Active comparator | After removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. The local anesthetic was injected between the erector spinae muscle and the transverse process using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms. Receives: Procedure: Bilateral Ultrasound-Guided Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Postoperative Tramadol Consumption During the First 24 Hours
The total amount of tramadol delivered through intravenous patient-controlled analgesia was calculated for each participant. The patient-controlled analgesia device was programmed to deliver a 15 mg tramadol bolus with a 15-minute lockout interval. Tramadol consumption recorded during the postoperative observation periods was summed and reported in milligrams. The standardized intraoperative tramadol dose administered to all participants was not included in this outcome.
Measured: From arrival in the post-anesthesia care unit through 24 hours after surgery
Secondary outcomes (7)
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Postoperative pain intensity was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain. Scores were recorded separately at each predefined postoperative assessment time. Higher scores indicated greater pain intensity.
Measured: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Patient-Controlled Analgesia Demand Count
The number of tramadol demands registered by the intravenous patient-controlled analgesia device was recorded for each postoperative assessment interval. The device was programmed to deliver a 15 mg tramadol bolus with a 15-minute lockout interval.
Measured: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Tramadol Consumption at Individual Postoperative Assessment Times
The amount of tramadol delivered through intravenous patient-controlled analgesia during each predefined postoperative assessment interval was recorded and reported in milligrams. This outcome evaluated the temporal pattern of postoperative tramadol consumption separately from cumulative 24-hour consumption.
Measured: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Requirement for Additional Postoperative Analgesia
The number of participants requiring additional postoperative analgesia was recorded. Participants with a Visual Analog Scale pain score of 4 or higher received 1,000 mg of intravenous paracetamol. Additional analgesic use was recorded separately at each assessment time and cumulatively during the first 24 postoperative hours.
Measured: From post-anesthesia care unit arrival through 24 hours after surgery
Postoperative Nausea and Vomiting Score
Postoperative nausea and vomiting were assessed using a 5-point scale: 0, no nausea; 1, nausea without vomiting; 2, nausea with one episode of vomiting; 3, nausea with two or three episodes of vomiting; and 4, nausea with more than three episodes of vomiting. Higher scores indicated more severe postoperative nausea and vomiting.
Measured: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Requirement for Rescue Antiemetic Medication
The number of participants requiring rescue antiemetic medication was recorded. Participants with a postoperative nausea and vomiting score of 1 or higher received 4 mg of intravenous ondansetron. Antiemetic use was recorded separately at each assessment time and cumulatively during the first 24 postoperative hours.
Measured: From post-anesthesia care unit arrival through 24 hours after surgery
Incidence of Block-Related Complications
Participants were monitored for complications related to the regional anesthesia procedures, including intravascular or neural injection, infection, hematoma or bleeding, pneumothorax, local anesthetic systemic toxicity, block failure, and inadequate analgesia. The number of participants experiencing at least one complication was recorded.
Measured: From block administration through 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 posted7 Aug 2026
- Study start20 Feb 2025
- Primary completion1 Dec 2025
- Study completion2 Dec 2025
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.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach, and the other group received a bilateral ultrasound-guided erector spinae plane block.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Yazman Arınç, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751770
- Sponsor's protocol ID
- MTAPA-ESP
- Other IDs
- 2024-KAEK-18
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 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 Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07751770
- Acronym / sponsor ID
- MTAPA-ESP
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Keywords
- Postoperative Analgesia, Modified Thoracoabdominal Nerve Block Through Perichondrial Approach, M-TAPA Block, Erector Spinae Plane Block, Ultrasound-Guided Regional Anesthesia, Tramadol Consumption, Acute Postoperative Pain, Patient-Controlled Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 7 Aug 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 study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block.
Adults undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly assigned to receive one of these two nerve blocks on both sides of the body before awakening from anesthesia. Both techniques used bupivacaine as the local anesthetic.
After surgery, pain intensity, tramadol consumption, need for additional pain medication, nausea and vomiting, antiemetic use, and block-related complications were assessed during the first 24 postoperative hours. The main objective was to determine whether the two techniques differed in their ability to reduce postoperative tramadol consumption and provide effective pain relief.
Detailed description
This was a prospective, single-center, randomized, parallel-group controlled study conducted in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Eligible participants were 18 to 65 years of age and had an American Society of Anesthesiologists physical status classification of I to III.
After providing written informed consent, participants were randomly assigned using a sealed-envelope method to one of two study groups. Participants in the first group received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. Participants in the second group received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. Both blocks were performed with 0.25% bupivacaine after removal of the gallbladder and before extubation.
General anesthesia and perioperative multimodal analgesia were standardized for both groups. Following surgery, all participants received intravenous patient-controlled analgesia with tramadol. Additional paracetamol was administered when the Visual Analog Scale pain score was 4 or higher. Ondansetron was administered when postoperative nausea or vomiting was present.
The primary outcome was cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes included Visual Analog Scale pain scores, patient-controlled analgesia demand, tramadol consumption at individual assessment times, additional analgesic requirement, postoperative nausea and vomiting, antiemetic requirement, and block-related complications. Outcomes were assessed upon arrival in the post-anesthesia care unit and at 30 minutes and 2, 3, 6, and 24 hours after surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach, and the other group received a bilateral ultrasound-guided erector spinae plane block.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Modified Thoracoabdominal Nerve Block Through Perichondrial Approach | Experimental | Procedure: Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial ApproachAfter removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. The block was performed at the inferior surface of the 10th costal cartilage using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms. |
| Bilateral Erector Spinae Plane Block | Active comparator | Procedure: Bilateral Ultrasound-Guided Erector Spinae Plane BlockAfter removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. The local anesthetic was injected between the erector spinae muscle and the transverse process using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 65 years
- Scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologists physical status I to III
- Body mass index below 35 kg/m²
- International Normalized Ratio and platelet count within the institutional reference ranges
Key exclusion criteria (13 listed)
- Bleeding diathesis
- Known allergy to local anesthetics
- Infection or inflammation at the planned block application site
- Gallbladder perforation
- Known neurological 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 |
|---|---|---|
| Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial ApproachAfter removal of the gallbladder and before extubation, the block was performed bilaterally under ultrasound guidance. The external oblique, internal oblique, and transversus abdominis muscles were identified at the inferior margin of the 10th costal cartilage. A block needle was advanced using an in-plane technique toward the inferior surface of the costal cartilage. After confirmation of the needle position with 2 to 3 mL of normal saline, 20 mL of 0.25% bupivacaine was administered on each side. | Procedure or surgery | Bilateral Modified Thoracoabdominal Nerve Block Through Perichondrial Approach |
| Bilateral Ultrasound-Guided Erector Spinae Plane BlockAfter removal of the gallbladder and before extubation, the block was performed bilaterally under ultrasound guidance at the T7 vertebral level. The needle was advanced using an in-plane technique until its tip was positioned between the erector spinae muscle and the transverse process. After confirmation of the needle position with 2 to 3 mL of normal saline, 20 mL of 0.25% bupivacaine was administered on each side. | Procedure or surgery | Bilateral Erector Spinae Plane Block |
Primary outcome
Cumulative Postoperative Tramadol Consumption During the First 24 Hours
Time frame: From arrival in the post-anesthesia care unit through 24 hours after surgery
The total amount of tramadol delivered through intravenous patient-controlled analgesia was calculated for each participant. The patient-controlled analgesia device was programmed to deliver a 15 mg tramadol bolus with a 15-minute lockout interval. Tramadol consumption recorded during the postoperative observation periods was summed and reported in milligrams. The standardized intraoperative tramadol dose administered to all participants was not included in this outcome.
7 secondary outcomes
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Time frame: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Patient-Controlled Analgesia Demand Count
Time frame: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Tramadol Consumption at Individual Postoperative Assessment Times
Time frame: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Requirement for Additional Postoperative Analgesia
Time frame: From post-anesthesia care unit arrival through 24 hours after surgery
Postoperative Nausea and Vomiting Score
Time frame: At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery
Requirement for Rescue Antiemetic Medication
Time frame: From post-anesthesia care unit arrival through 24 hours after surgery
Incidence of Block-Related Complications
Time frame: From block administration through 24 hours after surgery
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 7 Aug 2026.
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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 study testing Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach and Bilateral Ultrasound-Guided Erector Spinae Plane Block in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi 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 7 inclusion and 13 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 7 Aug 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?
Cumulative Postoperative Tramadol Consumption During the First 24 Hours (time frame: From arrival in the post-anesthesia care unit through 24 hours after surgery). 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 7 Aug 2026.