Open Radical Prostatectomy and Erector Spinae Plane Block

BURHAN DOST

Status: Completed

Conditions: Anesthesia, Local; Pain, Postoperative; Prostate Cancer

Treatments: Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham; Other: Pain follow-up and monitorization; Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04337060

ESP0255

Details and patient eligibility

About

In the proposed study, a bilateral erector spinae plane (ESP) block [10 ml 1%lidocaine + 10 ml 0.5 % bupivacaine vs normal saline (NS)] will be performed preoperatively to patients undergoing open radical prostatectomy. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intra- and 24 h post-operative narcotic consumption.

Full description

It has been reported that the ESP block produces effective postoperative analgesia for abdominal surgeries by relieving both somatic and visceral pain. In the present study, the investigators presume that an ESP block will decrease narcotic consumption and NRS values both intraoperatively and during the first 24 postoperative hours.

Patients will be divided into two groups:

Group LB (Lidocaine-Bupivacaine): A bilateral ESP block will be performed preoperatively (10 ml 1%lidocaine + 10 ml 0.5% bupivacaine). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.

Group S: A bilateral ESP block will be performed preoperatively (20 ml NS).In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: AmericanSociety of Anesthesiologists (ASA) I-III patients between the ages of 18 and 65 who are scheduled for elective open radical prostatectomy.

Exclusion criteria:

• Patients who do not give informed consent or do not want to participate in the study
• Ages <18 or>65
• ASA IV patients
• Obesity (>100 kg, BMI >35 kg/m2)
• Contraindications of regional anesthesia (coagulopathy, thrombocytopenia, or infection at injection site)
• Serious renal, cardiac, or hepatic disease
• Hypersensitivity to local anesthetics or a history of allergy
• History of opioid or steroid use longer than four weeks
• Psychiatric disorders
• Analgesic preoperative treatment within the preceding 48 hours
• In order to establish better standard surgery, operations shorter than 60 minutes and longer than 180 minutes will also be excluded

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Group LB

Active Comparator group

Description:

Ultrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia.

Treatment:

Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine

Other: Pain follow-up and monitorization

Group S

Sham Comparator group

Description:

Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.

Treatment:

Other: Pain follow-up and monitorization

Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham