Efficacy Of M-TAPA and TAP Block Following Laparoscopic Cholecystectomy
- Conditions
- Cholecystitis
- Interventions
- Other: Transversus Abdominal Plane blockOther: Modified Perichondral Approach Thoracoabdominal Nerve block
- Registration Number
- NCT06198335
- Lead Sponsor
- Mursel Ekinci
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- American Society of Anesthesiologists (ASA) classification I-II
- Elective laparoscopic cholecystectomy
- Bleeding diathesis
- Anticoagulant treatment
- Local anesthetics and opioid allergy
- Infection at the site of block
- Patients who do not accept the procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group TAP (Transversus Abdominal Plane block group) Transversus Abdominal Plane block Patients will be performed to block at the end of the surgery. Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered. Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group) Modified Perichondral Approach Thoracoabdominal Nerve block Patients will be performed to block at the end of the surgery. Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered.
- Primary Outcome Measures
Name Time Method Global recovery scoring system (patient satisfaction scale) 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 Outcome Measures
Name Time Method 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. Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
The use of rescue analgesia Meperidine consumption will be recorded at the first 24 hours period postoperatively.(total mg dose) The need for rescue analgesia will be recorded at the first 24 hours period postoperatively.
Trial Locations
- Locations (1)
Mürsel Ekinci
🇹🇷Bursa, Turkey