Postoperative Pain
Conditions
Brief summary
To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)
Interventions
PROCEDUREErector Spinae Plane Block
Patients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side.
PROCEDUREIntrathecal morphine
Patients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2, * patients with the American Society of Anesthesiologists (ASA) physical status I - II, * Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.
Exclusion criteria
* Patient's refusal * Allergy or contraindications to the study drugs, * Infection at the site of injection, * Coagulopathy, * Psychiatric disorders * Severely co-morbid patients, * Chronic pain syndromes, * Prolonged opioid medication,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption | 24 hours postoperatively | Nalbuphine consumption in mg equivalent to morphine dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic drug consumption other than nalbuphine | at 8, 24, 48, and 72 hours postoperatively. | consumption in mg |
| Numerical Rating Scale (NRS) at rest and when coughing | at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively | NRS is an 11-point (0=no pain and 10=worst pain) |
| Nalbuphine consumption in mg | at 8, 48, and 72 hours postoperatively. | equivalent to morphine dose |
| Mean Arterial Pressure | Intraoperatively | Mean Arterial Pressure in mmHg |
| Incidence of Postoperative nausea & vomiting (PONV) | 24 hours postoperatively | Number of patients developing PONV |
| Heart Rate | Intraoperatively | Heart Rate in beats /min |
Countries
Egypt
Outcome results
None listed