Open Radical Prostatectomy and Erector Spinae Plane Block

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: May 1, 2021

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.

Interventions

  • 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).
  • 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: 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).

Arms, Groups and Cohorts

  • 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.
  • Sham Comparator: Group S
    • Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Only Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BURHAN DOST
  • Collaborator
    • Ondokuz Mayıs University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: BURHAN DOST, Assistant Professor – Ondokuz Mayıs University
  • Overall Official(s)
    • BURHAN DOST, Study Director, Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
  • Overall Contact(s)
    • BURHAN DOST, 05327042493, burhandost@hotmail.com

References

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.

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.

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.

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.

Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andrés 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. Review.

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.

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.

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