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CompletedNCT06384677Updated Aug 26, 2024

Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

An interventional study of M-Tapa Block in Abdominal Cancer and Abdomen Disease, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Marmara University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Abdominal Cancer
  • Abdomen Disease

Keywords

  • major abdominal surgery
  • M-TAPA
  • opioid consumption
  • postoperative analgesia
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In context

Lead sponsor

Marmara University is the lead sponsor of 590 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Other
    M-Tapa + IV PCA applied group

    After appropriate skin disinfection, the transversus abdominis, internal oblique and external oblique muscles were determined with a high-frequency linear probe (Esaote) at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal border. A 21-G, 80-mm peripheral block needle was placed in the cranial direction using the in-plane technique, the needle tip did not exceed the cranial edge of the 10th costal cartilage, and 20 ml of 0.25% bupivacaine was applied to the lower surface of the chondrium on both sides, right and left. .

    Other: M-Tapa Block

  • Other
    IV PCA applied group

    In the IV PCA group, the surgeon performed local infiltration with 40 mL of 0.25% bupivacaine around the incisions. All patients were provided postoperative analgesia with intravenous patient-controlled analgesia (IVHKA). When pain was expressed by the patient, the patient pressed a button and the IV HKA pump was programmed to deliver a 1 ml bolus dose with a 10-minute lockout interval and no background infusion allowed. Each 1 ml of IVHKA solution contains 1 mg of morphine.

    Other: M-Tapa Block

Interventions

  • OtherM-Tapa Block

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

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What researchers measure

Primary outcomes

  1. Opioid Consumption

    The postoperative opioid consumption

    Time frame: Postoperative 24 hours

Secondary outcomes

  1. NRS Scores

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

    Time frame: postoperative 24 hours

  2. the need for rescue analgesia

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

    Time frame: postoperative 24 hours

  3. side effects

    nausea- vomiting

    Time frame: postoperative 24 hours

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Study locations

1 site
  • Marmara University Pendik Research and Training Hospital
    Istanbul, Turkey (Türkiye)
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References and documents

Publications

  • Hoyme U, Baumueller A, Madsen PO. Antibiotics excretion in canine vaginal and urethral secretions. Invest Urol. 1978 Jul;16(1):35-8. PubMed 29017 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06384677
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Apr 25, 2024
Start date
Apr 20, 2023
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024
Last update
Aug 26, 2024

Study contacts

GAMZE ÇABAKLI
study chair · Marmara Univercity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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