Postoperative PainNCT04474873
Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?
A study testing erector spinae block in people with Postoperative Pain and Nephrolithotomy, Percutaneous, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Nephrolithotomy, Percutaneous, Erector Spinae Plane Block
- What is being tested?
- erector spinae block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Aug 2020
- 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
- patients undergoing PNL between 18-65 years old
Who cannot join
- serious cardiac, respiratory, hepatic, renal or haemotologic disease
- mental disorder and hearing problem
- anxiety, depression and / or other psychiatric disorders
- pregnancy
- refusal of patient
- Allergy or contraindications to drugs used in the study
- ASA > 2 Inflammation or infection over injection site Obese patients BMI ≥35/
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?
This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.
Read the detailed description
Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.
Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.
- Being tested
- erector spinae block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae blockProcedure or surgery
we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Conventional intravenous analgesia | No intervention | Conventional intravenous analgesia applied according to surgeon's preference |
| Group 2:ESPB | Active comparator | A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used Receives: Procedure: erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Measured: postoperative 24 hours
Dynamic Visual Analog Scale
the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart
Measured: postoperative 24 hours
Peak Expiratory Flow Rate( PEFR)
maximum speed of expiration as measured with a peak flow meter
Measured: postoperative 24 hours
Secondary outcomes (9)
Time for first analgesic requirement
Time between end of surgery and patients first analgesic demand
Measured: 24 hours
ambulation time
first postoperative mobilization time of the patient
Measured: 5 days
length of hospital stay
day of hospitalization
Measured: 1 week
Rikert Agitation Scale
postoperative agitation score
- unarousable
- very sedated
- sedated
- calm and cooperative
- agitated
- very agitated
- dangerous agitation
Measured: 24 hours
nausea and vomiting
incidence of nausea and vomiting
Measured: 24 hours
patient satisfaction with anesthesia and analgesia
4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)
Measured: 24 hour
starting oral intake
first oral intake
Measured: 48 hours
urinary catheter releated pain score(Visual Analog Scale)
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Measured: postoperative 24 hours
surgeon satisfaction with anesthesia and analgesia
4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Mar 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, semih başkan, Ankara City Hospital Bilkent
- Investigators
- Semih Baskan, 2, Study director, Ankara City Hospital Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474873
- Sponsor's protocol ID
- E1-20-315
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 31620856
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?
- ClinicalTrials.gov ID
- NCT04474873
- Acronym / sponsor ID
- E1-20-315
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 17 Jul 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.
This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.
Detailed description
Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.
Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Conventional intravenous analgesia | No intervention | –Conventional intravenous analgesia applied according to surgeon's preference |
| Group 2:ESPB | Active comparator | Procedure: erector spinae blockA 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing PNL between 18-65 years old
Key exclusion criteria (7 listed)
- serious cardiac, respiratory, hepatic, renal or haemotologic disease
- mental disorder and hearing problem
- anxiety, depression and / or other psychiatric disorders
- pregnancy
- refusal of patient
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 |
|---|---|---|
| erector spinae blockwe administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound. | Procedure or surgery | Group 2:ESPB |
Primary outcome
Visual Analog Scale
Time frame: postoperative 24 hours
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Dynamic Visual Analog Scale
Time frame: postoperative 24 hours
the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart
Peak Expiratory Flow Rate( PEFR)
Time frame: postoperative 24 hours
maximum speed of expiration as measured with a peak flow meter
9 secondary outcomes
Time for first analgesic requirement
Time frame: 24 hours
ambulation time
Time frame: 5 days
length of hospital stay
Time frame: 1 week
Rikert Agitation Scale
Time frame: 24 hours
nausea and vomiting
Time frame: 24 hours
patient satisfaction with anesthesia and analgesia
Time frame: 24 hour
starting oral intake
Time frame: 48 hours
urinary catheter releated pain score(Visual Analog Scale)
Time frame: postoperative 24 hours
surgeon satisfaction with anesthesia and analgesia
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- 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.
- Individual participant dataSharing planned: No
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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.
Semih Baskan, 2 study director
Ankara City Hospital Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae block in people with Postoperative Pain and Nephrolithotomy, Percutaneous, run by Ankara City Hospital Bilkent 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. 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. 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?
Results are not available in the source record.
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?
Visual Analog Scale (time frame: postoperative 24 hours). The study lists 3 primary outcomes in all. 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 NCT04474873, which also lists 1 linked publication.
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 17 Jul 2020.