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Open Radical Prostatectomy and Erector Spinae Plane Block

Primary Purpose

Prostate Cancer, Anesthesia, Local, Pain, Postoperative

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

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

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

Pain follow-up and monitorization

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Pain, Postoperative, Ultrasound Guided Erector Spinae Plane Block, Prostatectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ondokuz Mayis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group LB

Group S

Arm Description

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

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

Outcomes

Primary Outcome Measures

Narcotic consumption in the first 24 hours after surgery

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

Postoperative pain: NRS score

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 nausea and vomiting (PONV)

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

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.

Full Information

NCT ID

NCT04337060

First Posted

April 3, 2020

Last Updated

December 23, 2021

Sponsor

BURHAN DOST

Collaborators

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT04337060

Brief Title

Open Radical Prostatectomy and Erector Spinae Plane Block

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

January 11, 2021 (Actual)

Study Completion Date

January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

BURHAN DOST

Collaborators

Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Anesthesia, Local, Pain, Postoperative

Keywords

Pain, Postoperative, Ultrasound Guided Erector Spinae Plane Block, Prostatectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group LB

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group S

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Other Intervention Name(s)

ESP block-Sham

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

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

Other Intervention Name(s)

ESP block-Lidocaine/Bupivacaine

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Pain follow-up and monitorization

Other Intervention Name(s)

IV morphine-PCA

Intervention Description

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).

Primary Outcome Measure Information:

Title

Narcotic consumption in the first 24 hours after surgery

Description

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.

Time Frame

Postoperative day 1

Secondary Outcome Measure Information:

Title

Postoperative pain: NRS score

Description

Time Frame

Postoperative day 1

Title

Postoperative nausea and vomiting (PONV)

Description

Time Frame

Postoperative day 1

Title

Intraoperative remifentanil consumption

Description

Time Frame

Postoperative day 1

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Only Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

BURHAN DOST

Organizational Affiliation

Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

Official's Role

Study Director

Facility Information:

Facility Name

Ondokuz Mayis University

City

Samsun

State/Province

Atakum

ZIP/Postal Code

55139

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

31620856

Citation

Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.

Results Reference

background

PubMed Identifier

27501016

Citation

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Results Reference

background

PubMed Identifier

28188621

Citation

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Results Reference

background

PubMed Identifier

32076689

Citation

Diwan S, Nair A. Is Paravertebral-Epidural Spread the Underlying Mechanism of Action of Erector Spinae Plane Block? Turk J Anaesthesiol Reanim. 2020 Feb;48(1):86-87. doi: 10.5152/TJAR.2019.81226. Epub 2019 Nov 11. No abstract available.

Results Reference

background

PubMed Identifier

30886130

Citation

Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.

Results Reference

background

PubMed Identifier

31031480

Citation

Tulgar S, Kapakli MS, Kose HC, Senturk O, Selvi O, Serifsoy TE, Thomas DT, Ozer Z. Evaluation of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: Randomized, Controlled, Prospective Study. Anesth Essays Res. 2019 Jan-Mar;13(1):50-56. doi: 10.4103/aer.AER_194_18.

Results Reference

background

PubMed Identifier

30988534

Citation

Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.

Results Reference

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Open Radical Prostatectomy and Erector Spinae Plane Block

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