- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337060
Open Radical Prostatectomy and Erector Spinae Plane Block
Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Atakum
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Samsun, Atakum, Turkey, 55139
- Ondokuz Mayis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
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).
Other Names:
|
Sham Comparator: Group S
Ultrasound-guided bilateral erector spinae plane block.
block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.
|
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).
Other Names:
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Postoperative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Postoperative day 1
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Postoperative nausea and vomiting (PONV)
Time Frame: Postoperative day 1
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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
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Postoperative day 1
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Intraoperative remifentanil consumption
Time Frame: Postoperative day 1
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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.
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Postoperative day 1
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: BURHAN DOST, Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Bupivacaine
- Morphine
Other Study ID Numbers
- ESP0255
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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