Prostate CancerNCT04337060
Open Radical Prostatectomy and Erector Spinae Plane Block
A study testing Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine and Pain follow-up and monitorization in people with Prostate Cancer and Anesthesia, Local, run by BURHAN DOST at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prostate Cancer, Anesthesia, Local, Pain, Postoperative
- What is being tested?
- Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine and Pain follow-up and monitorization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 11 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55139
About this study
Official title: Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial
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.
Read the 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.
- Conditions
- Prostate Cancer, Anesthesia, Local, Pain, Postoperative
- Being tested
- Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham, Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine, Pain follow-up and monitorization
- Keywords
- Pain, Postoperative, Ultrasound Guided Erector Spinae Plane Block, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-ShamProcedure or surgery
Also called 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).
Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/BupivacaineProcedure or surgery
Also called ESP 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).
Pain follow-up and monitorizationOther
Also called IV morphine-PCA
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).
| Study group | Role | What they receive |
|---|---|---|
| Group LB | Active comparator | Ultrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia. Receives: Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine; Other: Pain follow-up and monitorization |
| Group S | Sham comparator | Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia. Receives: Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham; Other: Pain follow-up and monitorization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic consumption in the first 24 hours after surgery
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.
Measured: Postoperative day 1
Secondary outcomes (3)
Postoperative pain: NRS score
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.
Measured: Postoperative day 1
Postoperative nausea and vomiting (PONV)
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
Measured: Postoperative day 1
Intraoperative remifentanil consumption
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.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 May 2020
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- BURHAN DOST
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, BURHAN DOST, Ondokuz Mayıs University
- Investigators
- BURHAN DOST, Study director, Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337060
- Sponsor's protocol ID
- ESP0255
- Status last verified
- Dec 2021
- First submitted
- 3 Apr 2020
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31620856Forero 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.
PubMed 27501016Chin 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.
PubMed 28188621Diwan 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.
PubMed 32076689Kot 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.
PubMed 30886130Tulgar 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.
PubMed 31031480Singh 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.
PubMed 30988534
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT04337060
- Acronym / sponsor ID
- ESP0255
- Conditions
- Prostate Cancer, Anesthesia, Local, Pain, Postoperative
- Keywords
- Pain, Postoperative, Ultrasound Guided Erector Spinae Plane Block, Prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- BURHAN DOSTUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group LB | Active comparator | Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine, Other: Pain follow-up and monitorizationUltrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia. |
| Group S | Sham comparator | Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham, Other: Pain follow-up and monitorizationUltrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-ShamAlso: ESP block-ShamWith 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 or surgery | Group S |
| Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/BupivacaineAlso: ESP block-Lidocaine/BupivacaineWith 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). | Procedure or surgery | Group LB |
| Pain follow-up and monitorizationAlso: IV morphine-PCANumeric 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 | Group LB, Group S |
Primary outcome
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.
3 secondary outcomes
Postoperative pain: NRS score
Time frame: Postoperative day 1
Postoperative nausea and vomiting (PONV)
Time frame: Postoperative day 1
Intraoperative remifentanil consumption
Time frame: Postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Background: PubMed 31620856Ibrahim 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.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 28188621Chin 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.
- Background: PubMed 32076689Diwan 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.
- Background: PubMed 30886130Kot 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.
- Background: PubMed 31031480Tulgar 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.
- Background: PubMed 30988534Singh 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.
Related trials for Prostate Cancer
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingObservational study
Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
Prostate Cancer
RecruitingObservational study
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
Prostate Cancer
RecruitingPhase 1/2
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
Cancer Of Prostate, Prostate Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BURHAN DOST study director
Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine and Pain follow-up and monitorization in people with Prostate Cancer and Anesthesia, Local, run by BURHAN DOST at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic consumption in the first 24 hours after surgery (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337060, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021; AzTrials last refreshed its copy on 30 Oct 2026.