Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach in Patients Undergoing Laparoscopic Cholecystectomy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Laparoscopic Cholecystectomy
- Sponsor
- Karaman Training and Research Hospital
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Numerical Rating Scale scores
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy.
Detailed Description
Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this block are lacking. In this prospective interventional trial, the investigators aim to define the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general anesthesia. This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, the patients in the Group M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study
Exclusion Criteria
- •presence of coagulation disorder
- •refuse to participate
- •infection at the injection site of the block
- •known allergy to local anesthetics
- •advanced hepatic or renal failure
- •can not communicate in Turkish
- •history of abdominal surgery or trauma
- •conversion of laparoscopic to open surgery
- •consumption of any pain killers within the 24 h before the operation
- •chronic opioid consumption
Outcomes
Primary Outcomes
Numerical Rating Scale scores
Time Frame: 24 hours
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
Secondary Outcomes
- Sedation score(24 hours)
- Opioid consumption(24 hours)
- Adverse events(24 hours)
- Metoclopromide consumption(24 hours)
- Quality of recovery levels between groups by using QoR-40 questionnaire(Postoperative 24th hour)