Ultrasound Guided Bilateral Erector Spinae Plane Block in Retropubic Radical Prostatectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Ultrasound guided erector spinae plane block; Other: Standard Pain Followup and Monitorization

• Registration Number: NCT03413163
• Lead Sponsor: Maltepe University

Brief Summary

This study will define the postoperative analgesic effect of ESP block via amount of patient-controlled analgesia (PCA) and postoperative analgesic consumption (such as routinely and rescue analgesics) and compare the control group patients with retropubic radical prostatectomy .

Detailed Description

Open retropubic prostatectomy is a surgical method that is applied in cases of benign prostatic hypertrophy and prostate cancer which is not suitable for surgical treatment with closed method. This method is commonly used among urological procedures which are open surgical procedures. Patients after this procedure often complain of excessive pain. Non-steroidal anti-inflammatory agents and opioids are used for postoperative analgesia. In addition, in the past decade, in the guideline of ultrasonography, peripheral block types have been described that demonstrate analgesic activity in open prostatectomies as well as many operations on the development of regional anesthesia and analgesia techniques. The ultrasonography guideline reported that the transverse abdominal plane (TAP) block provides effective analgesia in these cases. The ESP block is a new block for the treatment of thoracic neuropathic pain. In the following process; ESP block thoracic and breast surgery, bariatric surgery, and upper abdominal surgeons have also been reported to provide effective postoperative analgesia.

The standard practice for post-operative pain management for retropubic radical prostatectomy in Maltepe University Hospital consists of routine intravenous analgesic and rescue analgesics and in combination with patient-controlled analgesia (PCA).

The application of erector spinae plane (ESP) block technique under ultrasonography guideline under sedoanalgesia in patients who will undergo retropubic prostatectomy with open method should determine the effect on the patient's pain level in the first 24 hours after operation.

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-02-01
• Primary Completion: 2018-04-15
• Study Completion: 2018-04-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Elective retropubic radikal prostatectomy, ASA status 1-2

Exclusion Criteria

• Patient refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Inability to provide informed consent
• Severe kidney or liver disease
• Inability to operate PCA system
• Patient with psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block	Standard Pain Followup and Monitorization	In addition to routine analgesic protocol; before anaesthesia induction; bilateral ultrasound guided erector spinae plane block (ESP) (intervention) will be performed via USG guidance at Th9 level.Standard Pain Followup and Monitorization will be performed. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
ESP block	Ultrasound guided erector spinae plane block	In addition to routine analgesic protocol; before anaesthesia induction; bilateral ultrasound guided erector spinae plane block (ESP) (intervention) will be performed via USG guidance at Th9 level.Standard Pain Followup and Monitorization will be performed. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
control	Standard Pain Followup and Monitorization	Peroperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. Intervention: Other: Standard Pain Followup and Monitorization

Primary Outcome Measures

Name	Time	Method
Changes in Numeric Rating Scale (NRS)	24 hours	Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Secondary Outcome Measures

Name	Time	Method
analgesic consumption	24 hours	Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using

Trial Locations

Locations (1)

Maltepe University Medical Faculty; 🇹🇷 Istanbul, Feyzullah No:39, Turkey