Postoperative Pain
Conditions
Keywords
Cholecystectomy, ESP block, Port Site Infiltration
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.
Interventions
PROCEDUREErector spinae plane block
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.
PROCEDUREPort 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 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.
DEVICEUltrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.
DRUGBupivacaine 0.5%
Bupivacaine 0.5% will be included in the injected LA mixture.
DRUGLidocaine 2%
Lidocaine 2% will be included in the injected LA mixture.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid consumption. | 24 hours postoperatively | Nalbuphine consumption in mg.(equivalent to morphine dose) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed