Clinical trial NCT06230289: Effect of Transversus Abdominis Plane Block on Diaphragm Thickness
Official title: Effect of 4 Point TAP Block on Diaphragm Thickness in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragm; Relaxation
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diaphragma thickness as milimeter
timeFrame: Preoperative measurement of DT and postoperative measurement of DT(5. minutes and 30. minutes)
Secondary outcomes:
measure: Visual Analog Scale (from 1 to 10)
timeFrame: VAS assessment preoperatively and postoperatively at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours.
measure: Opioid consumption as miligram per day
timeFrame: 2, 8, and 24 hours postoperatively assessments
measure: Quality of Recovery-15T score (from 0 to150)
timeFrame: 24 hours postoperatively assessments
Other outcomes:
Locations:
city: Meram
country: Turkey
facility: Nuran Akıncı
state: Konya
Study officials:
affiliation: Konya City Hospital
name: Nuran Akıncı, MD
role: PRINCIPAL_INVESTIGATOR
References: