- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413163
Ultrasound Guided Bilateral Erector Spinae Plane Block in Retropubic Radical Prostatectomy
Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Retropubic Radical Prostatectomy Patients; Randomised, Controlled Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Feyzullah No:39
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Istanbul, Feyzullah No:39, Turkey, 34843
- Maltepe University Medical Faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: control
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 |
Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours.
Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room.
It is planned that the patient will continue to follow the hourly NRS score in ward.
Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours.
Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
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Experimental: ESP 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 |
Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours.
Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room.
It is planned that the patient will continue to follow the hourly NRS score in ward.
Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours.
Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process.
The erector spinae muscles will be identified superficial to the tip of T9 transverse process.
The patient's skin will be anesthetized with 2% lidocaine.
A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle.
The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process.
A total of 30 mL of 0.375% bupivacaine will be injected (maximum of 3mg/kg).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Numeric Rating Scale (NRS)
Time Frame: 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").
|
24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
analgesic consumption
Time Frame: 24 hours
|
Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ozgur senturk, ass prof, Maltepe University Faculty of Medicine
Publications and helpful links
General Publications
- 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.
- Restrepo-Garces CE, Chin KJ, Suarez P, Diaz A. Bilateral Continuous Erector Spinae Plane Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321. doi: 10.1213/XAA.0000000000000605.
- Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Maltepe University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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