Effect of Transversus Abdominis Plane Block on Diaphragm Thickness

Effect of 4 Point TAP Block on Diaphragm Thickness in Patients Undergoing Laparoscopic Cholecystectomy

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

Study Overview

• Status: Completed
• Conditions: Diaphragm; Relaxation
• Intervention / Treatment: Procedure: Transabdominal plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya
    • Meram, Konya, Turkey, 42020
      • Nuran Akıncı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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

Collaborators and Investigators

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: Nuran Akıncı, MD, Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DiaTap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After performing the study, we might share all info with the system.
• IPD Sharing Time Frame: We want to describe the time frame after finish the study as completed.
• IPD Sharing Access Criteria: We can share the data by using e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No