Open Radical Prostatectomy and Erector Spinae Plane Block

December 23, 2021 updated by: BURHAN DOST

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55139
        • Ondokuz Mayis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group LB
Ultrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia.
Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine

With the patient in the sitting position, 10 ml 1% lidocaine + 10 ml 0.5% bupivacaine will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane.

Intraoperative analgesia: After anesthesia induction, paracetamol 1 gr IV + tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg).

Postoperative analgesia: IV PCA of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit).

Other Names:
  • ESP block-Lidocaine/Bupivacaine
Other: Pain follow-up and monitorization
Numeric Rating Scale (NRS) pain score will be recorded from 15th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours with two different conditions which are at rest and while couching.If NRS score becomes ≥4 Dexketoprofen 50 mg will be administered (max 4 times).
Other Names:
  • IV morphine-PCA
Sham Comparator: Group S
Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.
Other: Pain follow-up and monitorization
Numeric Rating Scale (NRS) pain score will be recorded from 15th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours with two different conditions which are at rest and while couching.If NRS score becomes ≥4 Dexketoprofen 50 mg will be administered (max 4 times).
Other Names:
  • IV morphine-PCA
Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham

With the patient in the sitting position, 20 ml normal saline will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane.

Intraoperative analgesia: after anesthesia induction, paracetamol 1 gr intravenous (IV)+ tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg).

Postoperative analgesia: IV morphine patient-controlled analgesia (PCA) of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit).

Other Names:
  • ESP block-Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: NRS score
Time Frame: 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.
Postoperative day 1
Postoperative nausea and vomiting (PONV)
Time Frame: 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
Postoperative day 1
Intraoperative remifentanil consumption
Time Frame: 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 day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BURHAN DOST

Collaborators

Ondokuz Mayıs University

Investigators

  • Study Director: BURHAN DOST, Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

January 11, 2021

Study Completion (Actual)

January 11, 2021

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP0255

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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