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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | During the fascia block application, the injection will be administered using the conventional method without any specific time limit. |
|
| One-minute injection | Active Comparator | During the fascia block application, the injection will be administered within 1 minute. |
|
| Two-minute injection | Active Comparator | During the fascia block application, the injection will be administered within 2 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group O | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| sensory block distribution | 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. | Postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | 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" | Postoperative 24 hours |
| tramadol consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Korgün Ökmen, PhD. | Contact | 05057081021 | korgunokmen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Yuksek Ihtisas Training and Research Hospital | Bursa | 16110 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| C106365 | O-antigen, Acinetobacter strain 90 |
| D012681 | Sensitivity Training Groups |
| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Group T | Drug | 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. |
|
| Group C | Drug | 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. |
|
| Postoperative 24 hours] |
| Pressure values | Pressure values (mm/hg) measured using the infusion device during block application. | During the procedure |