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Completed

NCT Number: NCT06384677

Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.

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Key information

Conditions

Abdominal Cancer Abdomen Disease

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patient > 17 years old
  • ASA score 1-3
  • undergoing major intra-abdominal surgery

Exclusion criteria

  • ASA IV patients
  • patients with known neurological or psychiatric disorders
  • patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
  • patients with long-term drug (opioid) or alcohol dependence
  • patients with BMI>30
  • patients with intellectual disability
  • patients who developed massive bleeding and coagulopathy

Treatment and study plan

m-tapa block

Other

M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery

Primary outcomes

  1. Opioid Consumption

    Time frame: Postoperative 24 hours

    The postoperative opioid consumption

Secondary outcomes

  1. NRS Scores

    Time frame: postoperative 24 hours

    Numeric Rating Scale score (rating from 1 to 10. 1:no pain to 10: worst pain ever)

  2. the need for rescue analgesia

    Time frame: postoperative 24 hours

    if NRS>4: apply rescue analgesia: the total count of rescue analgesia need

  3. side effects

    Time frame: postoperative 24 hours

    nausea- vomiting

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2024
Registry last updated
Aug 26, 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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