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Postoperative PainNCT07881536

Comparison of M-TAPA, EOIP, and Local Infiltration for Pain Relief After Laparoscopic Cholecystectomy

An observational study of Postoperative Pain and Cholecystectomy, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This retrospective observational study aimed to compare three pain management techniques used after laparoscopic gallbladder removal (cholecystectomy): modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA), external oblique intercostal plane (EOIP) block, and local anesthetic infiltration. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain, Cholecystectomy, Laparoscopic
What is being tested?
Modified Thoracoabdominal Nerve Block Through the Perichondrial Approach, External Oblique Intercostal Plane Block and Local anesthetic infiltration
Type of treatment
Surgery or procedure
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Jan 2025to 16 Apr 2025
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consisted of adult patients aged 18 years or older with American Society of Anesthesiologists (ASA) physical status I-II who underwent elective laparoscopic cholecystectomy under general anesthesia at Pamukkale University Hospital, Türkiye, between January and April 2025. Patients were identified retrospectively from routinely collected hospital medical records and categorized according to the postoperative analgesic technique received: modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA), external oblique intercostal plane (EOIP) block, or local anesthetic infiltration. Of 135 initially assessed patients, 90 met the eligibility criteria and were included in the final analysis, with 30 patients in each group.

Who may be able to join

  • Adults aged 18 years or older.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Patients who underwent elective laparoscopic cholecystectomy under general anesthesia between January and April 2025.
  • Patients who received M-TAPA block, EOIP block, or local anesthetic infiltration as part of routine clinical care.
  • Availability of complete medical records for postoperative pain assessment and analgesic outcomes

Who cannot join

  • Major organ failure, including renal, hepatic, or cardiac failure.
  • Significant cardiovascular conditions, including atrioventricular block, unstable angina, myocardial infarction within the preceding 6 weeks, heart rate below 50 beats/min, or systolic blood pressure below 90 mmHg.
  • Body mass index (BMI) ≥35 kg/m².
  • Neurological or psychiatric disorders that could impair communication or pain assessment.
  • Use of antidepressant medications, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or mirtazapine.
  • Patients requiring additional surgical procedures.
  • Patients undergoing anesthesia other than general anesthesia.
  • Incomplete medical records.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Pamukkale University Hospital

    Merkezefendi, Denizli, 20000

Other trials in Turkey (Türkiye)

About this study

Official title: Postoperative Analgesic Efficacy of M-TAPA and External Oblique Intercostal Plane Blocks Versus Local Infiltration in Laparoscopic Cholecystectomy: A Retrospective Cohort Study

This retrospective observational study aimed to compare three pain management techniques used after laparoscopic gallbladder removal (cholecystectomy): modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA), external oblique intercostal plane (EOIP) block, and local anesthetic infiltration.

The study included 90 adult patients who underwent elective laparoscopic cholecystectomy between January and April 2025. Patients were divided into three groups according to the pain management technique they received during routine clinical care, with 30 patients in each group.

Read more

The primary outcome was pain intensity measured 2 hours after surgery using a visual analog scale (VAS). Additional outcomes included pain scores at 15 minutes and 4, 8, 16, and 24 hours after surgery, the need for additional opioid pain medication, and opioid-related adverse events.

The study aimed to evaluate differences in postoperative pain control and the need for additional pain medication among these three techniques using previously collected medical records.

Read the detailed description

This single-center retrospective observational study was conducted at Pamukkale University Hospital, Turkey, using routinely collected clinical data from patients who underwent elective laparoscopic cholecystectomy between January and April 2025.

Adult patients aged 18 years or older with American Society of Anesthesiologists (ASA) physical status I-II were eligible for inclusion. During routine clinical care, postoperative analgesic techniques had been assigned using a sequentially numbered, opaque, sealed-envelope procedure. The investigators conducting the subsequent retrospective analysis were not involved in treatment allocation.

Three analgesic techniques were evaluated:

M-TAPA Group: Patients received an ultrasound-guided bilateral modified thoracoabdominal nerve block through the perichondrial approach, with 20 mL of 0.25% bupivacaine administered on each side.

EOIP Group: Patients received an ultrasound-guided bilateral external oblique intercostal plane block, with 20 mL of 0.25% bupivacaine administered on each side.

Local Infiltration Group: Patients received local anesthetic infiltration around the four laparoscopic port sites using a total of 20 mL of 0.50% bupivacaine.

All patients underwent standardized general anesthesia and received routine perioperative analgesic treatment.

A total of 135 patients had been allocated during routine clinical care. Following retrospective application of the predefined eligibility criteria, 45 patients were excluded, leaving 90 patients for analysis (30 in each group).

Postoperative pain intensity during movement was evaluated using the visual analog scale (VAS) at 15 minutes and 2, 4, 8, 16, and 24 hours after surgery. The primary outcome was the VAS pain score at 2 hours. Secondary outcomes included pain scores at the remaining assessment times, the proportion of patients requiring rescue opioid analgesia, and the incidence of opioid-related adverse events.

The study compared postoperative analgesic outcomes associated with the three techniques under routine clinical practice conditions. Because the analysis was retrospective and the total local anesthetic dose differed between groups, the findings were interpreted as observational associations rather than definitive causal effects.

Being tested
Modified Thoracoabdominal Nerve Block Through the Perichondrial Approach, External Oblique Intercostal Plane Block, Local anesthetic infiltration
Keywords
Cholecystectomy, Postoperative Pain, External Oblique Intercostal Plane Block, Modified Thoracoabdominal Nerve Block Through Perichondrial Approach
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Thoracoabdominal Nerve Block Through the Perichondrial ApproachProcedure or surgery

    Bilateral ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) was performed after completion of laparoscopic cholecystectomy. Under sterile conditions, 20 mL of 0.25% bupivacaine was injected on each side into the fascial plane between the transversus abdominis muscle and the costochondral structure, for a total volume of 40 mL. The procedure was performed as part of routine clinical care.

  • External Oblique Intercostal Plane BlockProcedure or surgery

    Bilateral ultrasound-guided external oblique intercostal plane (EOIP) block was performed after completion of laparoscopic cholecystectomy. Under sterile conditions, 20 mL of 0.25% bupivacaine was injected on each side into the fascial plane between the external oblique and intercostal muscles at the level of the sixth and seventh ribs, for a total volume of 40 mL. The procedure was performed as part of routine clinical care.

  • Local anesthetic infiltrationProcedure or surgery

    Local anesthetic infiltration was performed by the surgeon at the end of laparoscopic cholecystectomy. A total of 20 mL of 0.50% bupivacaine was administered around the four laparoscopic port sites, with approximately 5 mL injected at each site. The procedure was performed as part of routine clinical care.

Study groups in NCT07881536
Study groupRoleWhat they receive
M-TAPA BlockPatients who received bilateral ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) as part of routine clinical care. A total of 20 mL of 0.25% bupivacaine was administered on each side (40 mL total). This group included 30 patients undergoing elective laparoscopic cholecystectomy.
Receives: Procedure: Modified Thoracoabdominal Nerve Block Through the Perichondrial Approach
EOIP BlockPatients who received bilateral ultrasound-guided external oblique intercostal plane (EOIP) block as part of routine clinical care. A total of 20 mL of 0.25% bupivacaine was administered on each side (40 mL total). This group included 30 patients undergoing elective laparoscopic cholecystectomy.
Receives: Procedure: External Oblique Intercostal Plane Block
Local Anesthetic InfiltrationPatients who received local anesthetic infiltration around the four laparoscopic port sites as part of routine clinical care. A total of 20 mL of 0.50% bupivacaine was administered, with approximately 5 mL injected at each port site. This group included 30 patients undergoing elective laparoscopic cholecystectomy.
Receives: Procedure: Local anesthetic infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity at 2 Hours

    Postoperative pain intensity during movement was assessed using the Visual Analog Scale (VAS) 2 hours after laparoscopic cholecystectomy. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less postoperative pain. VAS scores were compared among the M-TAPA, EOIP, and local anesthetic infiltration groups.

    Measured: 2 hours after surgery

Secondary outcomes (6)
  1. Postoperative Pain Intensity at 15 Minutes

    Postoperative pain intensity during movement was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. VAS scores were compared among the M-TAPA, EOIP, and local anesthetic infiltration groups.

    Measured: 15 minutes after surgery

  2. Postoperative Pain Intensity at 4 Hours

    Postoperative pain intensity during movement was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. VAS scores were compared among the M-TAPA, EOIP, and local anesthetic infiltration groups.

    Measured: 4 hours after surgery

  3. Postoperative Pain Intensity at 8 Hours

    Postoperative pain intensity during movement was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. VAS scores were compared among the M-TAPA, EOIP, and local anesthetic infiltration groups.

    Measured: 8 hours after surgery

  4. Postoperative Pain Intensity at 16 Hours

    Postoperative pain intensity during movement was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. VAS scores were compared among the M-TAPA, EOIP, and local anesthetic infiltration groups.

    Measured: 24 hours after surgery

  5. Proportion of Patients Requiring Rescue Opioid Analgesia

    The proportion of patients requiring additional opioid analgesia after surgery was assessed using routinely collected medical records. Rescue opioid requirement was recorded as a binary outcome (yes/no) and compared among the M-TAPA, EOIP, and local anesthetic infiltration groups. Results were expressed as the number and percentage of patients requiring rescue opioid treatment.

    Measured: Within 24 hours after surgery

  6. Incidence of Opioid-Related Adverse Events

    The incidence of opioid-related adverse events, including nausea, vomiting, pruritus, hypotension, bradycardia, respiratory depression, and sedation, was assessed using routinely collected postoperative medical records. The occurrence of these events was compared among the three analgesic groups.

    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.

  1. First posted19 Oct 2026
  2. Study start14 Jan 2025
  3. Primary completion16 Apr 2025
  4. Study completion16 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07881536
Sponsor's protocol ID
ext-obl1111
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in this study may be shared, including baseline demographic and perioperative characteristics, analgesic technique received (M-TAPA, EOIP, or local anesthetic infiltration), postoperative visual analog scale (VAS) pain scores at 15 minutes and 2, 4, 8, 16, and 24 hours, rescue opioid analgesia requirements, and opioid-related adverse events, including nausea, vomiting, pruritus, hypotension, bradycardia, respiratory depression, and sedation. Data will be made available upon reasonable request to the corresponding author and subject to applicable ethical and institutional requirements.

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain and Cholecystectomy, run by Pamukkale University 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 5 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 19 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 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?

Postoperative Pain Intensity at 2 Hours (time frame: 2 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 19 Oct 2026.

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