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NCT Number: NCT06662617

Analgesic Effect of M-TAPA and TAPB on Laparoscopic Cholesistectomy

Cholecystectomy is the most frequently performed abdominal surgery in developed nations, with laparoscopic cholecystectomy being recognized as the gold standard technique for treating gallstones.

The efficacy of TAP block for pain relief has been well-documented following laparoscopic cholecystectomy procedures. Recently, m-TAPA block has emerged as an alternative analgesic technique for abdominal surgeries.

This study aims to evaluate and compare the effectiveness of these two analgesic methods in managing postoperative pain after laparoscopic cholecystectomy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicana Sivas Hospital

Sivas, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hüseyin Özden, associate professor

CONTACT

[email protected]

+905070117130

About this study

Cholecystectomy is the most commonly performed abdominal surgery in developed countries, with laparoscopic cholecystectomy regarded as the gold standard technique for gallstone treatment.

Postoperative pain following laparoscopic cholecystectomy is influenced by several factors, making it a complex and predominantly visceral pain. These factors include phrenic nerve irritation due to CO2 insufflation, abdominal distension, port site incisions, the effects of gallbladder removal, and individual patient characteristics.

Regional analgesia has gained widespread acceptance from both patients and physicians, becoming a key component of multimodal analgesia techniques. The transversus abdominis plane (TAP) block has proven effective in reducing postoperative pain in surgeries such as hysterectomy, cholecystectomy, cesarean section, and colorectal procedures.

The Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) involves administering a local anesthetic to the underside of the perichondral surface. This technique provides effective analgesia for the anterior and lateral thoracoabdominal regions.

The purpose of this study is to compare the efficacy of US-guided M-TAPA block with TAP block for postoperative analgesia following cholecystectomy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of
  • Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion criteria

  • Patients who did not give consent,
  • patients with coagulopathy,
  • patients with signs of infection at the block application site,
  • patients using anticoagulants,
  • patients with local anesthetic drug allergies,
  • patients undergoing open surgery,
  • patients with unstable hemodynamics,
  • patients who could not cooperate during postoperative pain assessment

Treatment and study plan

modified thoracoabdominal nerve block through perichondrial approach

Other

After the patient fell asleep, surgery was not yet started. Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.

Transversus Abdominal Plane block

Other

After the patient fell asleep, surgery was not yet started. Following sterile conditions for bilateral TAP block application, USG will be placed transversely on the mid-axillary line between the iliac crest and subcostal planes. Using the In Plane technique, the block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline . After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.

Primary outcomes

  1. numerical rating scale scores

    Time frame: postoperative 24 hours

    numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Secondary outcomes

  1. total tramadol consumption

    Time frame: postoperative 24 hours

    postoperative analgesic need

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

Comparison of the Effects of M-TAPA and TAP Nerve Block Applications on Postoperative Pain Scores and Analgesia Requirements in Laparoscopic Cholecystectomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Nov 6, 2024

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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