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NCT Number: NCT05207306

Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Please Select An Option, 03080, South Korea

About this study

Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled to undergo elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) physical classification I-II

Exclusion criteria

  • American Society of Anesthesiologists (ASA) physical classification III or more
  • Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
  • Allergies to anesthetic or analgesic medications used in the protocol
  • Single port laparoscopic cholecystectomy
  • Patients with infection at the abdominal wall
  • Medical or psychological disease that can affect the treatment response
  • Do not understand our study

Treatment and study plan

Type of interfascial plane block

Procedure

In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way.

In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.

Primary outcomes

  1. Maximum postoperative pain score during 12hours postoperatively

    Time frame: at 12hour postoperatively.

    maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively

Secondary outcomes

  1. Postoperative pain score at rest

    Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge

    Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting

  2. Postoperative pain score during coughing

    Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge

    Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing

  3. Patient satisfaction before discharge

    Time frame: at immediately before discharge

    Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction)

  4. Occurrence rate of postoperative nausea, vomiting

    Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.

    Incidence of postoperative nausea and vomiting (%)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2022
Registry last updated
Aug 22, 2023

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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