Open Radical Prostatectomy and Erector Spinae Plane Block

Not Applicable

Completed

• Conditions: Pain, Postoperative; Prostate Cancer; Anesthesia, Local
• Interventions: Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham; Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine; Other: Pain follow-up and monitorization

• Registration Number: NCT04337060
• Lead Sponsor: BURHAN DOST

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Study Start: 2020-05-01
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham	Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.
Group LB	Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine	Ultrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia.
Group LB	Pain follow-up and monitorization	Ultrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia.
Group S	Pain follow-up and monitorization	Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.

Primary Outcome Measures

Name	Time	Method
Narcotic consumption in the first 24 hours after surgery	Postoperative day 1	Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting (PONV)	Postoperative day 1	The patients will be verbally evaluated according to a descriptive five-point PONV scale. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once;and 4 = vomiting more than once
Intraoperative remifentanil consumption	Postoperative day 1	Following anesthesia induction, a bispectral index (BIS) of 40 to 50 will be maintained with sevoflurane. When the BIS measures 40-50, the remifentanil infusion rate will be adjusted to consider ±20% blood pressure changes compared to baseline values.The total amount of remifentanil consumed will be recorded.
Postoperative pain: NRS score	Postoperative day 1	Pain status at rest and while coughing will be assessed by NRS score at 1, 3, 6, 12, 18, and 24 hours after surgery. In addition, the time until first analgesic requirement will be recorded.The NRS is an 11-point numeric scale which ranges from 0 to 10.

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Atakum, Turkey