Diaphragm; Relaxation Clinical Trial
Official title:
Effect of 4 Point TAP Block on Diaphragm Thickness in Patients Undergoing Laparoscopic Cholecystectomy
Verified date | June 2024 |
Source | Konya City Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypothesis: Postoperative pain, by preventing effective diaphragmatic contraction, hinders deep inspiration and expiration. Inspiratory and expiratory levels can be assessed by measuring diaphragm thickness using ultrasound.Diaphragm thickness[DT] measured at the end of inspiration and expiration will differ between patients who undergo Transversus Abdominis Plane Block[TAP] block using the 4-point technique and those who do not. It is anticipated that in patients who receive the block, diaphragm thickness will be greater, serving as an indicator of
Status | Active, not recruiting |
Enrollment | 86 |
Est. completion date | June 15, 2024 |
Est. primary completion date | June 12, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Written informed consent; 2. 18-65 years old; 3. ASA Physical Status 1-2; 4. Scheduled for elective kolesistektomi. Exclusion Criteria: 1. =18, =65 years old; 2. Any contraindications nerve blocks; 3. VKI>35 kg/m2; 4. Bleeding diathesis; 5. Switching to open surgery; 6. Language barrier; 7. Having undergone upper abdominal surgery previously; 8. Severe kind of chronic lung ilness; 9. Contraindication or allergy to planned drugs. |
Country | Name | City | State |
---|---|---|---|
Turkey | Nuran Akinci | Meram | Konya |
Lead Sponsor | Collaborator |
---|---|
Konya City Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragma thickness as milimeter | Measurement of Diaphragm Thickness: Patients will be placed in a supine position with the head elevated 30 degrees, and high-frequency linear probe ultrasound (DC-60 Diagnostic Ultrasound, Shenzhen Mindray, China) will be used to visualize the diaphragm in its characteristic three-layered appearance above the anterior axillary line at the aponeurosis region (lung-pleura). The hypoechoic (dark) muscle tissue between the two hyperechoic (bright) lines of pleural and peritoneal fascia will be imaged, and the thickness will be measured and recorded. | Preoperative measurement of DT and postoperative measurement of DT(5. minutes and 30. minutes) | |
Secondary | Visual Analog Scale (from 1 to 10) | Secondary outcome measures will include preoperative and postoperative assessments at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours, using the Visual Analog Scale (VAS) to evaluate pain for both resting and movement (0-10, 0 = no pain, 10 = the most severe pain). | VAS assessment preoperatively and postoperatively at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours. | |
Secondary | Opioid consumption as miligram per day | Secondary outcome measures include preoperative, 5 minutes post-extubation, 30 minutes post-extubation, and 2, 8, and 24 hours postoperatively assessments of total tramadol consumption, the number of patients requiring postoperative rescue analgesia, nausea, vomiting. | 2, 8, and 24 hours postoperatively assessments | |
Secondary | Quality of Recovery-15T score (from 0 to150) | Secondary outcome measures include 24 hours postoperatively assessments of the patient recovery score evaluated with QoR-15T will also be recorded. Results: The QoR-15 scores for Excellent: 136-150, Good:122-135, Moderate:90-121, Poor recovery: 0-89. | 24 hours postoperatively assessments |
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