Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
- Conditions
- Postoperative Pain
- Interventions
- Procedure: Port site infiltrationProcedure: Erector spinae plane blockDevice: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
- Registration Number
- NCT04167176
- Lead Sponsor
- Assiut University
- Brief Summary
To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
- Patients scheduled for elective laparoscopic cholecystectomy.
-
Allergy to local anaesthetics,
-
Infection at the site of injection,
•, Coagulopathy,
-
Chronic pain syndromes,
-
Prolonged opioid medication,
-
Patients who received any analgesic 24 h before surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Port site infiltration technique Lidocaine 2% After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites Port site infiltration technique Bupivacaine 0.5% After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites Erector spinae plane block Lidocaine 2% ultrasound guided ESP Block after anaesthesia induction Port site infiltration technique Port site infiltration After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites Erector spinae plane block Bupivacaine 0.5% ultrasound guided ESP Block after anaesthesia induction Erector spinae plane block Erector spinae plane block ultrasound guided ESP Block after anaesthesia induction Erector spinae plane block Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China) ultrasound guided ESP Block after anaesthesia induction
- Primary Outcome Measures
Name Time Method Total postoperative opioid consumption. 24 hours postoperatively Nalbuphine consumption in mg.(equivalent to morphine dose)
- Secondary Outcome Measures
Name Time Method Pain scores;Numerical Rating Scale (NRS) at rest and when coughing at 1, 2,4 , 8, 16 and 24 hours postoperatively. The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).
•Cumulative postoperative analgesic consumption 24 hours postoperatively Analgesic drug consumption other than nalbuphine in mg.
•Heart Rate (HR) Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery Heart Rate in beats /min
•Mean Arterial Pressure (MAP) Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery Mean Arterial Pressure in mmHg
Incidence and severity Postoperative nausea & vomiting (PONV). 24 hours postoperatively Number of patients developing PONV \& PONV Score; (1) No nausea or vomiting, (2) only nausea but no vomiting, (3) single episode of vomiting or persistent nausea, and (4) two or more episodes of vomiting or severe retching.
Trial Locations
- Locations (1)
Assiut University hospital
🇪🇬Assiut, Asyut Governorate, Egypt