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Clinical Trials/NCT04337060
NCT04337060
Completed
Not Applicable

Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial

BURHAN DOST1 site in 1 country52 target enrollmentMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
BURHAN DOST
Enrollment
52
Locations
1
Primary Endpoint
Narcotic consumption in the first 24 hours after surgery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
January 11, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
BURHAN DOST
Responsible Party
Sponsor Investigator
Principal Investigator

BURHAN DOST

Assistant Professor

Ondokuz Mayıs University

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Narcotic consumption in the first 24 hours after surgery

Time Frame: 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 Outcomes

  • Postoperative nausea and vomiting (PONV)(Postoperative day 1)
  • Intraoperative remifentanil consumption(Postoperative day 1)
  • Postoperative pain: NRS score(Postoperative day 1)

Study Sites (1)

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