Nerve Block
Conditions
Brief summary
This prospective observational study aims to evaluate the impact of injection duration during fascial plane blocks on block success and analgesic efficacy in patients undergoing laparoscopic cholecystectomy. The hypothesis is that shorter injection durations increase injection pressure, potentially limiting local anesthetic spread, while longer durations facilitate broader anesthetic distribution.
Detailed description
Fascial plane blocks involve injecting local anesthetics between two anatomical fascial layers, with analgesia achieved by anesthetic diffusion through the fascial plane. However, anesthetic spread may vary significantly based on injection technique, speed, and pressure. This study hypothesizes that injection duration directly influences injection pressure, local anesthetic distribution, and consequently, the extent of sensory blockade and analgesia.
Interventions
DRUGGroup O
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed Drug: Tramadol 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.
DRUGGroup T
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed Drug: Tramadol 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.
DRUGGroup C
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed Drug: Tramadol 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
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
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 |
|---|---|---|
| sensory block distribution | Postoperative 24 hours | The distribution of sensory block will be evaluated using pinprick and cold tests at 2, 6, 12 and 24 hours after surgery. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt. |
Secondary
| 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 |
| tramadol consumption | Postoperative 24 hours] | — |
| Pressure values | During the procedure | Pressure values (mm/hg) measured using the infusion device during block application. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactKorgün Ökmen, PhD.
Outcome results
None listed