Open Radical Prostatectomy and Erector Spinae Plane Block

NCT04337060 | Completed

• 1 other identifier: ESP0255
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Anesthesia, Local; Pain, Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative day 1

Secondary Outcomes (3)

• Postoperative pain: NRS score

  Postoperative day 1

• Postoperative nausea and vomiting (PONV)

  Postoperative day 1

• Intraoperative remifentanil consumption

  Postoperative day 1

Study Arms (2)

Group LB

ACTIVE COMPARATOR

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; Other: Pain follow-up and monitorization

Group S

SHAM COMPARATOR

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

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

Interventions

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

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).

Also known as: ESP block-Sham

Group S

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

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).

Also known as: ESP block-Lidocaine/Bupivacaine

Group LB

Pain follow-up and monitorization OTHER

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).

Also known as: IV morphine-PCA

Group LB; Group S

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• BURHAN DOST: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 31620856 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 28188621 BACKGROUND

• 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.

  PMID: 32076689 BACKGROUND

• 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.

  PMID: 30886130 BACKGROUND

• 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.

  PMID: 31031480 BACKGROUND

• 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.

  PMID: 30988534 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Pain, Postoperative

Interventions

Parapsychology; Bupivacaine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• BURHAN DOST

  Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: May 1, 2020
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

TU (1)