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Ultrasound Guided Bilateral Erector Spinae Plane Block in Retropubic Radical Prostatectomy

M

Maltepe University

Status

Completed

Conditions

Postoperative Pain

Treatments

Other: Standard Pain Followup and Monitorization
Drug: Ultrasound guided erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT03413163
Maltepe University

Details and patient eligibility

About

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 .

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

control
Sham Comparator group
Description:
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
Treatment:
Other: Standard Pain Followup and Monitorization
ESP block
Experimental group
Description:
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
Treatment:
Other: Standard Pain Followup and Monitorization
Drug: Ultrasound guided erector spinae plane block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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