PainNCT04118413
Ultrasound Guided Bilateral Erector Spinae Plane Block in Caesarean Delivery
A study testing erector spinae plane block in people with Pain, run by Cigli Regional Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years ago. Its use for many indications has been identified by case reports in the literature. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2019to 17 Dec 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing cesarean section under spinal anesthesia
Who cannot join
- patients undergoing cesarean section under general anesthesia morbidly 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, recent use of analgesic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Ultrasound Guided Low Thoracic Erector Spinae Plane Block for Postoperative Analgesia in Caesarean Delivery
Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that ESPB could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral low thoracic ESPB in cesarean section.
- Conditions
- Pain
- Being tested
- erector spinae plane block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockOther
Erector espine plane block will be administrated bilaterally to this group at low thoracic level (Th11).
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Experimental | Erector spinae plane block will be administrated to this group at end of the surgery under spinal anesthesia. An intravenous patient-controlled analgesia device within morphine will be given to the patients postoperatively and sheduled paracetamol will be given. Receives: Other: erector spinae plane block |
| Control Group | No intervention | In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with morphine and sheduled paracetamol. No block will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours opioid consumption
morphine consumptions for both group will be recorded
Measured: 24 hour
Secondary outcomes (1)
Numeric rating scale for postoperative pain intensity
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").
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 posted8 Oct 2019
- Study start14 Oct 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cigli Regional Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Aygün, Cigli Regional Training Hospital
- Investigators
- Aygun, Principal investigator, izmir cigli regional hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118413
- Sponsor's protocol ID
- ESPB for CD
- Status last verified
- Dec 2019
- First submitted
- 5 Oct 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.
PubMed 29352577Santonastaso DP, de Chiara A, Addis A, Mastronardi C, Pini R, Agnoletti V. Ultrasound guided erector spinae plane block for post-operative pain control after caesarean section. J Clin Anesth. 2019 Dec;58:45-46. doi: 10.1016/j.jclinane.2019.05.009. Epub 2019 May 7. No abstract available.
PubMed 31075624Aygun H, Thomas DT, Tulgar S. Comment to Santonastaso et al. 'J Clin Anesth 2019; 58: 45-46' and report of erector spinae plane block series in caesarean delivery patients. J Clin Anesth. 2020 Mar;60:4-5. doi: 10.1016/j.jclinane.2019.08.008. Epub 2019 Aug 16. No abstract available.
PubMed 31425897
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound Guided Low Thoracic Erector Spinae Plane Block for Postoperative Analgesia in Caesarean Delivery
- ClinicalTrials.gov ID
- NCT04118413
- Acronym / sponsor ID
- ESPB for CD
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cigli Regional Training HospitalUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 8 Oct 2019 (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.
Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that ESPB could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral low thoracic ESPB in cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Experimental | Other: erector spinae plane blockErector spinae plane block will be administrated to this group at end of the surgery under spinal anesthesia. An intravenous patient-controlled analgesia device within morphine will be given to the patients postoperatively and sheduled paracetamol will be given. |
| Control Group | No intervention | –In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with morphine and sheduled paracetamol. No block will be performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients undergoing cesarean section under spinal anesthesia
Key exclusion criteria (1 listed)
- patients undergoing cesarean section under general anesthesia morbidly 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, recent use of analgesic drugs
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 espine plane block will be administrated bilaterally to this group at low thoracic level (Th11). | Other | Erector spinae plane block |
Primary outcome
24 hours opioid consumption
Time frame: 24 hour
morphine consumptions for both group will be recorded
1 secondary outcome
Numeric rating scale for postoperative pain intensity
Time frame: 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 18 Dec 2019.
- Results publication: PubMed 29352577Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.
- Results publication: PubMed 31075624Santonastaso DP, de Chiara A, Addis A, Mastronardi C, Pini R, Agnoletti V. Ultrasound guided erector spinae plane block for post-operative pain control after caesarean section. J Clin Anesth. 2019 Dec;58:45-46. doi: 10.1016/j.jclinane.2019.05.009. Epub 2019 May 7. No abstract available.
- Results publication: PubMed 31425897Aygun H, Thomas DT, Tulgar S. Comment to Santonastaso et al. 'J Clin Anesth 2019; 58: 45-46' and report of erector spinae plane block series in caesarean delivery patients. J Clin Anesth. 2020 Mar;60:4-5. doi: 10.1016/j.jclinane.2019.08.008. Epub 2019 Aug 16. No abstract available.
- 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.
Aygun principal investigator
izmir cigli regional hospital
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 in people with Pain, run by Cigli Regional Training Hospital 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 1 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 18 Dec 2019. 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?
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?
24 hours opioid consumption (time frame: 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 NCT04118413, which also lists 3 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 18 Dec 2019.