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Clinical Trials/NCT06198335
NCT06198335
Recruiting
Not Applicable

Comparison Of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach and Transversus Abdominal Plane Block in Analgesia Efficacy And Recovery Quality Following Laparoscopic Cholecystectomy

Mursel Ekinci1 site in 1 country60 target enrollmentJanuary 20, 2024
ConditionsCholecystitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholecystitis
Sponsor
Mursel Ekinci
Enrollment
60
Locations
1
Primary Endpoint
Global recovery scoring system (patient satisfaction scale)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Cholecystectomy is the most common abdominal surgical procedure in developed countries Laparoscopic cholecystectomy is considered the gold standard surgical technique for gallstones.

The analgesic effectiveness of TAP block has been demonstrated after laparoscopic cholecystectomy operations. m-TAPA block has been described as an alternative analgesic technique in abdominal surgeries.

The aim of this study is to compare these two analgesic methods in terms of effectiveness for postoperative analgesia management after laparoscopic cholecystectomy operations.

Detailed Description

Cholecystectomy is the most common abdominal surgical procedure in developed countries Laparoscopic cholecystectomy is considered the gold standard surgical technique for gallstones. Several factors play a role in pain after laparoscopic cholecystectomy. This pain is complex and generally considered to be visceral. These factors are include phrenic nerve irritation caused by CO2 insufflation, abdominal distension, port incisions, the effect of gallbladder removal and individual factors. Regional analgesia has been widely accepted by both patients and treating physicians and has become an important part of multimodal analgesia techniques. Transversus abdominis plane (TAP) block has been shown to reduce postoperative pain like hysterectomy, cholecystectomy, cesarean section and colorectal surgery. Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) is performed by applying local anesthetic only to the underside of the perichondral surface. It provides effective analgesia in the anterior and lateral thoracoabdominal area. M-TAPA is a good alternative for analgesia of the upper dermatome levels and lateral abdominal region and may be an opioid-sparing strategy that provides better quality recovery in patients undergoing laporoscopic surgery. M-TAPA provides analgesia at the T5-T11 level in the abdomen. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen with US guidance. Cephalo caudal spread of local anesthetic solution produces analgesia in several dermatomes. There are studies investigating the efficacy of M-TAPA for postoperative pain management in bariatric surgery in the literature. Global recovery score (QoR) 15 is a sensitive, reliable and easy method to measure postoperative recovery quality. This scale, which has become a promising tool for assessing the quality of the recovery period, questions various aspects of recovery in 5 different areas: pain, physical comfort, physical independence, psychological support and emotional state. It may be an important scale to evaluate the outcome of changes in healthcare for quality assurance purposes in perioperative clinical studies. For these reasons, the "Standardized Endpoints in Perioperative Medicine" initiative and the European Society of Anesthesia have recommended the use of the QoR-15 scale in clinical studies investigating patient comfort and pain levels after surgery. The aim of this study was to compare the efficacy of US-guided M-TAPA block and TAP for postoperative analgesia management after cholecystectomy. The primary outcome is to compare global recovery scores, the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative rescue analgesic (opioid) use and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.

Registry
clinicaltrials.gov
Start Date
January 20, 2024
End Date
May 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mursel Ekinci
Responsible Party
Sponsor Investigator
Principal Investigator

Mursel Ekinci

Assoc prof

Bursa City Hospital

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Elective laparoscopic cholecystectomy

Exclusion Criteria

  • Bleeding diathesis
  • Anticoagulant treatment
  • Local anesthetics and opioid allergy
  • Infection at the site of block
  • Patients who do not accept the procedure

Outcomes

Primary Outcomes

Global recovery scoring system (patient satisfaction scale)

Time Frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

The investigators will use the Turkish version of Quality of Recovery / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

Secondary Outcomes

  • Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")(Patients will be evaluated at the first 24 hours period postoperatively.)
  • The use of rescue analgesia(Meperidine consumption will be recorded at the first 24 hours period postoperatively.(total mg dose))

Study Sites (1)

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