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Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

M

Marmara University

Status

Completed

Conditions

Abdominal Cancer
Abdomen Disease

Treatments

Other: M-Tapa Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06384677
03.03.2023/371

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

M-Tapa + IV PCA applied group
Other group
Description:
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. .
Treatment:
Other: M-Tapa Block
IV PCA applied group
Other group
Description:
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.
Treatment:
Other: M-Tapa Block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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