Postoperative Pain, Laparoscopic Cholecystectomy, Regional Anesthesia
Conditions
Brief summary
Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.
Detailed description
In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.
Interventions
PROCEDUREM-TAPA block
ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed
PROCEDUREEXORA block
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
DRUGTramadol
400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
prospective, single-blind, observational study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* laparoscopic cholecystectomy surgery * Patients with ASA (American Society of Anaesthetists) scores I and III will be included.
Exclusion criteria
* Uncontrolled Arterial Hypertension * Uncontrolled Diabetes Mellitus, * Mental retardation , * Antidepressant use * Metabolic disorders, * Bleeding diathesis * Patients with a body mass index above 30.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS | Postoperative 24 hours | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tramadol consumption | Postoperative 24 hours | — |
| side effect profile scores | Postoperative 24 hours | 1\. Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of \>3, an anti-emetic drug was administered. |
| additional analgesic use | Postoperative 24 hours | additional analgesic use |
| pinprick test | Postoperative 24 hours | The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt. |
| Ramsay Sedation Scale | Postoperative 24 hours | Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated,awake; 3. Sedated , response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap ) |
Countries
Turkey (Türkiye)
Outcome results
None listed