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NCT Number: NCT07751770

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

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.

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Key information

Conditions

Postoperative Pain Laparoscopic Cholecystectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Provincial Directorate of Health Sultan 2.Abdul Hamid Khan Educational and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach

Procedure

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 Block

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. Requirement for Additional Postoperative Analgesia

    Time frame: From post-anesthesia care unit arrival through 24 hours after surgery

    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.

  5. 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

    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.

  6. Requirement for Rescue Antiemetic Medication

    Time frame: From post-anesthesia care unit arrival through 24 hours after surgery

    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.

  7. Incidence of Block-Related Complications

    Time frame: From block administration through 24 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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