Effect of Transversus Abdominis Plane Block on Diaphragm Thickness

NCT ID: NCT06230289

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-06-30

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

Detailed Description

Postoperative pain is among the main reasons for the decrease in respiratory function after upper abdominal surgery. Numerous studies have investigated the relationship between pain and respiratory function in abdominal surgeries. While the classic TAP block is used to relieve lower abdominal pain [Th10-Th12] after surgery, it may be insufficient in relieving pain in the upper abdominal wall [Th6-Th9]. The 4-point TAPb technique is employed to address the pain in this region. Ultrasound allows for non-invasive assessment of changes in diaphragm thickness along with changes in lung volume, and evaluating diaphragm mass and contraction is highly useful in diagnosing respiratory diseases. Previous studies have explored changes in diaphragm thickness and the relationship between total lung capacity [TLC], functional residual capacity [FRC], residual volume [RV] and diaphragm function. However, changes in diaphragm function due to pain prevention in patients undergoing '4-point' TAPb are not well understood. It is aimed to investigate the impact of the 4-point TAP block on the diaphragm in patients undergoing laparoscopic cholecystectomy under general anesthesia. The primary objective of this study is to use ultrasound to examine the effect of the four-point TAP block, administered for analgesia after laparoscopic cholecystectomy, on diaphragm thickness. The secondary objective is to assess the impact of the four-point TAP block on pain and the quality of patient recovery.

Conditions

Diaphragm; Relaxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Group B: Transabdominal plane block group

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.

Group Type: ACTIVE_COMPARATOR

Transabdominal plane block

Intervention Type: 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 C: Control group with multi-modal analgesia

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transabdominal plane block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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. VKİ>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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nuran Akıncı Ekinci

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuran Akıncı, MD

Role: PRINCIPAL_INVESTIGATOR

Konya City Hospital

Locations

Nuran Akıncı

Meram, Konya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DiaTap

Identifier Type: -

Identifier Source: org_study_id