Postoperative PainNCT03744689
Erector Spinae Plane Block For Lumbar Disc Hernia Repair
A study testing Erector Spinae Plane block, Bupivacaine Hydrochloride and PCA in people with Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane block, Bupivacaine Hydrochloride and PCA
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 4 Feb 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
- ASA I-II
- Age 18-65 years
- Undergoing elective lomber disc hernia
Who cannot join
- obesity
- ASA III - IV
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation
Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane block, Sham block, Bupivacaine Hydrochloride, PCA
- Keywords
- Lomber disc hernia, Erector spinae plane block, Postoperative pain
- 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 Plane blockProcedure or surgery
Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride
Sham blockProcedure or surgery
Sham block will be done with serum physiologic.
Bupivacaine HydrochlorideDrug
20 ml 0,25% Bupivacaine will be used for block performances
PCADevice
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Erector Spinae Plane Block Group
Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks Receives: Procedure: Erector Spinae Plane block; Drug: Bupivacaine Hydrochloride; Device: PCA |
| Control Group | Sham comparator | Sham block will be done with serum physiologic. Receives: Procedure: Sham block; Device: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
morphine consumptions will be recorded
Measured: postoperative first 24 hour
Secondary outcomes (1)
Numeric rating scale
Numeric rating scale for pain will be used for pain evaluation. The scale is scored in a range of 0-10 with 0 representing no pain 10 representing the highest degree of pain.
Measured: postoperative first 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Oct 2019
- Primary completion1 Feb 2020
- Study completion4 Feb 2020
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.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek İçli, Kocaeli University
- Investigators
- Dilek Icli, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744689
- Sponsor's protocol ID
- KİA2018/440
- Status last verified
- Feb 2020
- First submitted
- 15 Nov 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yorukoglu HU, Icli D, Aksu C, Cesur S, Kus A, Gurkan Y. Erector spinae block for postoperative pain management in lumbar disc hernia repair. J Anesth. 2021 Jun;35(3):420-425. doi: 10.1007/s00540-021-02920-0. Epub 2021 Mar 22.
PubMed 33751203
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation
- ClinicalTrials.gov ID
- NCT03744689
- Acronym / sponsor ID
- KİA2018/440
- Conditions
- Postoperative Pain
- Keywords
- Lomber disc hernia, Erector spinae plane block, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 16 Nov 2018 (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.
Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane block, Drug: Bupivacaine Hydrochloride, Device: PCAErector Spinae Plane Block Group Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks |
| Control Group | Sham comparator | Procedure: Sham block, Device: PCASham block will be done with serum physiologic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- Age 18-65 years
- Undergoing elective lomber disc hernia
Key exclusion criteria (5 listed)
- obesity
- ASA III - IV
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
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 Plane blockErector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride | Procedure or surgery | Erector Spinae Plane Block |
| Sham blockSham block will be done with serum physiologic. | Procedure or surgery | Control Group |
| Bupivacaine Hydrochloride20 ml 0,25% Bupivacaine will be used for block performances | Drug | Erector Spinae Plane Block |
| PCAIntravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded | Device | Control Group, Erector Spinae Plane Block |
Primary outcome
Morphine consumption
Time frame: postoperative first 24 hour
morphine consumptions will be recorded
1 secondary outcome
Numeric rating scale
Time frame: postoperative first 24 hour
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 5 Feb 2020.
- Derived from this study: PubMed 33751203Yorukoglu HU, Icli D, Aksu C, Cesur S, Kus A, Gurkan Y. Erector spinae block for postoperative pain management in lumbar disc hernia repair. J Anesth. 2021 Jun;35(3):420-425. doi: 10.1007/s00540-021-02920-0. Epub 2021 Mar 22.
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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.
Dilek Icli principal investigator
Kocaeli University
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 Plane block, Bupivacaine Hydrochloride and PCA in people with Postoperative Pain, run by Kocaeli University 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 3 inclusion and 5 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 5 Feb 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. 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?
Morphine consumption (time frame: postoperative first 24 hour). 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 NCT03744689, 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 5 Feb 2020.