An observational study in Postoperative Pain, Cholecystectomy and Laparoscopic, sponsored by Pamukkale University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Pamukkale University · Observational
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.
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.
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 90 is close to the median of 100 across 622 observational studies indexed under Pain, Postoperative.
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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.
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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
Exclusion Criteria:
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.
Patients 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.
Procedure: Modified Thoracoabdominal Nerve Block Through the Perichondrial Approach
Patients 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.
Procedure: External Oblique Intercostal Plane Block
Patients 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.
Procedure: Local anesthetic infiltration
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.
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 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.
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.
Time frame: 2 hours after surgery
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.
Time frame: 15 minutes after surgery
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.
Time frame: 4 hours after surgery
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.
Time frame: 8 hours after surgery
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.
Time frame: 24 hours after surgery
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.
Time frame: Within 24 hours after surgery
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.
Time frame: Within 24 hours after surgery
Plan to share: 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.
Time frame: De-identified individual participant data will be available upon reasonable request following publication of the study results, for a period of 5 years after publication.
Access criteria: De-identified individual participant data will be available to qualified researchers upon reasonable request to the corresponding author. Requests should include a research proposal describing the objectives and planned analyses. Access will be subject to review by the corresponding author and applicable institutional and ethical requirements. Approved researchers may receive relevant anonymized datasets for scientific research purposes. No directly identifiable participant information will be shared.
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Ran from Jan 2025 to primary completion in Apr 2025, 3 months.
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