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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
44
Patients will be placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.
Assiut University hospital
Asyut, Asyut Governorate, Egypt
Total postoperative opioid consumption.
Nalbuphine consumption in mg.(equivalent to morphine dose)
Time frame: 24 hours postoperatively
Pain scores;Numerical Rating Scale (NRS) at rest and when coughing
The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).
Time frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively.
•Cumulative postoperative analgesic consumption
Analgesic drug consumption other than nalbuphine in mg.
Time frame: 24 hours postoperatively
•Heart Rate (HR)
Heart Rate in beats /min
Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
•Mean Arterial Pressure (MAP)
Mean Arterial Pressure in mmHg
Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Incidence and severity Postoperative nausea & vomiting (PONV).
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.
Time frame: 24 hours postoperatively
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Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.
Bupivacaine 0.5% will be included in the injected LA mixture.
Lidocaine 2% will be included in the injected LA mixture.