Effect of Transversus Abdominis Plane Block on Diaphragm Thickness

NCT06230289 | Completed

• 1 other identifier: DiaTap
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diaphragm; Relaxation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analog Scale (from 1 to 10)

  VAS assessment preoperatively and postoperatively at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours.

• Opioid consumption as miligram per day

  2, 8, and 24 hours postoperatively assessments

• Quality of Recovery-15T score (from 0 to150)

  24 hours postoperatively assessments

Study Arms (2)

Group B: Transabdominal plane block group

ACTIVE COMPARATOR

Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block.

Procedure: Transabdominal plane block

Group C: Control group with multi-modal analgesia

NO INTERVENTION

Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group C which will be performed no interventional procedures.

Interventions

Transabdominal plane block PROCEDURE

Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block, while no interventional procedures will be performed on patients in Group C.

Group B: Transabdominal plane block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• years old;
• ASA Physical Status 1-2;
• Scheduled for elective kolesistektomi.

You may not qualify if:

• ≤18, ≥65 years old;
• Any contraindications nerve blocks;
• VKİ\>35 kg/m2;
• Bleeding diathesis;
• Switching to open surgery;
• Language barrier;
• Having undergone upper abdominal surgery previously;
• Severe kind of chronic lung ilness;
• Contraindication or allergy to planned drugs.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Nuran Akıncı

Meram, Konya, 42020, Turkey (Türkiye)

Location

Study Officials

• Nuran Akıncı, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 30, 2024
• Study Start: December 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 30, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We want to describe the time frame after finish the study as completed.
• Access Criteria: We can share the data by using e-mail.

Locations

TU (1)