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NCT Number: NCT06483581

Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Appendectomy Surgeries

The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

There will be two randomized groups: Group M-TAPA (n=15), Group TAP (n=15). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed after general anesthesia induction, before skin incision. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients older than 18 years of age who will undergo laparoscopic appendectomy under general anesthesia and will be 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

M-TAPA block with bupivacaine 25%

Other

Following sterile conditions for bilateral M-TAPA block application, the transducer will be inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle will be created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip will be placed just below the chondrium and saline (5 ml) will be injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine will be administered for each group for a total of 40 ml of local anesthetic. Blocks will be applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose will be applied to the contralateral side for each group of M-TAPA patients.

Other names: Modified thoracoabdominal nerve block through perichondrial approach

TAP block with bupivacaine 25%

Other

After the necessary sterilization conditions established, the linear ultrasound probe will be placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum will be identified. As the tip of the 80 mm sonovisible needle passes through the muscular layers and fascia, the needle will be advanced in a controlled manner. After receiving the click sensation (passage of the fascia of the internal oblique muscle), the location of the needle will be fixed and 20 ml of 0.25% bupivacaine will be injected between internal oblique and transversus abdominis muscles. Same procedure will be performed to the other site. (40 ml local anesthetics in total)

Other names: Transversus abdominis plane block

Primary outcomes

  1. Comparing the numerical rating scale scores

    Time frame: Postoperative 24 hours

    Numerical rating scale will be 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. Comparing total tramadol consumption

    Time frame: Postoperative 24 hours

    Postoperative analgesic need

Study contacts

Contact information is provided by the study sponsor or research team.

Onur Avcı

CONTACT

[email protected]

+905301126408

Oğuz Gündoğdu

CONTACT

[email protected]

+905545945469

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Appendectomy Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jul 3, 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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