Pain, PostoperativeNCT05695625
The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under SpinalAnaesthesia
A study testing Spinal anesthesia + bilateral erector spine plane block and Spinal anesthesia in people with Pain, Postoperative, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Acute pain after cesarean section (SC) can be variable. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Spinal anesthesia + bilateral erector spine plane block and Spinal anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 1 Feb 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18-45 years, pregnants delivered by CS from May 2020 to June 2021
Who cannot join
- age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under Spinal Anaesthesia
Acute pain after cesarean section (SC) can be variable. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB), a recently defined interfacial plane block, provides multisegmental analgesia by spreading to both ventral and dorsal branches of the spinal nerve roots in the cranio-caudal plane with a single injection. The aim of this study is to evaluate the effects of ESPB on postoperative pain, analgesic use and patient satisfaction in patients delivered by CS under spinal anesthesia.
Read the detailed description
Cesarean section (CS) is one of the most common surgical procedures in the world. Acute pain intensity after cesarean section can be variable, making difficult to predict pain severity. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB) is a recently defined interfascial plane block. As a result of ultrasound (USG) guided local anesthetic drug injection into the fascial plane between erector spina muscle and vertebral transverse process, multisegmental analgesia provided by spreading to the both ventral and dorsal branches of the spinal nerve roots in cranio-caudal plane with a single injection. The primary aim of this study was to evaluate the effects of bilateral ESPB on postoperative pain, using the visual analog scale (VAS) in patients delivered by CS under spinal anesthesia. The secondary aims of the study are to evaluate the effects of ESPB on analgesic drug use and patient satisfaction in the postoperative period.
116 pregnants, aged between 18-45 years, delivered by CS from May 2020 to June 2021 included the prospective, randomised, single centre study. Exclusion criteria were age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study. Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace with 26G quincke spinal needle in the sitting position. At the end of the surgery, in ESPB group, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. At the postoperative 2, 4, 6, 12 and 24th hours, patients' rest, cough, movement, low back and headache VAS values, analgesic drug use, first analgesic use time and satisfaction were evaluated. ESPB spread level was evaluated with pin-prick at the 4-6th hours. The SPSS 11.5 program was used for statistical analysis.
- Conditions
- Pain, Postoperative
- Being tested
- Spinal anesthesia + bilateral erector spine plane block, Spinal anesthesia
- Keywords
- Erector spina plane block, postoperative pain, obstetric analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia + bilateral erector spine plane blockOther
Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. At the end of the surgery, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides.
Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered.
Spinal anesthesiaOther
Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position.
Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered.
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB | Active comparator | Spinal anesthesia + bilateral ESPB (total of 40 ml, %0.5 bupivacaine) Receives: Other: Spinal anesthesia + bilateral erector spine plane block |
| Group SA | Active comparator | Only spinal anesthesia Receives: Other: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
VAS scores at 2, 4, 6, 12 and 24th hours. (VAS is an 11 point numeric scale ranges from 0 to 10. )
Measured: 24 hours
Secondary outcomes (6)
Postoperative analgesic drug consumption
Diclofenac consumption in the first 24 hours was measured.
Measured: 24 hours
Need for rescue analgesic
The number of patients who required rescue analgesic in the first 24 hours and paracetamol consumption were recorded.
Measured: 24 hours
Number of patients with postoperative nausea-vomiting and need of antiemetic usage
Number of patients with postoperative nausea-vomiting and need of antiemetic usage were recorded.
Measured: 24 hours
Patients' satisfaction
At the postoperative 2, 4, 6, 12 and 24th hours patients' satisfaction was assessed using a descriptive verbal scale (11 point scale from 0 to 10. 0: not satisfied, 10: very satisfied).
Measured: 24 hours
First analgesic using time, first mobilization time, hospitalization time
Postoperative first analgesic using time, first mobilization time and hospitalization time were recorded.
Measured: Postoperative 4 days on an average
ESPB spread level
The range of sensory block level in ESPB group was evaluated as dermatomal after the effect of spinal anesthesia passed, at 4-6th hours with pin-prick test.
Measured: 4-6th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 May 2020
- Primary completion6 Jun 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmet Onat Bermede, Süheyla Karadağ Erkoç, Volkan Baytaş, Bulut Varlı, Hanife Asuman Uysalel
- Responsible party
- Principal investigator, Bengi Safak, Ankara University
- Investigators
- Bengi Şafak, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695625
- Sponsor's protocol ID
- AnkaraU-CS-ESPB
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT05695625
- Acronym / sponsor ID
- AnkaraU-CS-ESPB
- Conditions
- Pain, Postoperative
- Keywords
- Erector spina plane block, postoperative pain, obstetric analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Ahmet Onat Bermede, Süheyla Karadağ Erkoç, Volkan Baytaş, Bulut Varlı, Hanife Asuman Uysalel
- Study start
- 1 May 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 25 Jan 2023 (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.
Acute pain after cesarean section (SC) can be variable. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB), a recently defined interfacial plane block, provides multisegmental analgesia by spreading to both ventral and dorsal branches of the spinal nerve roots in the cranio-caudal plane with a single injection. The aim of this study is to evaluate the effects of ESPB on postoperative pain, analgesic use and patient satisfaction in patients delivered by CS under spinal anesthesia.
Detailed description
Cesarean section (CS) is one of the most common surgical procedures in the world. Acute pain intensity after cesarean section can be variable, making difficult to predict pain severity. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB) is a recently defined interfascial plane block. As a result of ultrasound (USG) guided local anesthetic drug injection into the fascial plane between erector spina muscle and vertebral transverse process, multisegmental analgesia provided by spreading to the both ventral and dorsal branches of the spinal nerve roots in cranio-caudal plane with a single injection. The primary aim of this study was to evaluate the effects of bilateral ESPB on postoperative pain, using the visual analog scale (VAS) in patients delivered by CS under spinal anesthesia. The secondary aims of the study are to evaluate the effects of ESPB on analgesic drug use and patient satisfaction in the postoperative period.
116 pregnants, aged between 18-45 years, delivered by CS from May 2020 to June 2021 included the prospective, randomised, single centre study. Exclusion criteria were age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study. Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace with 26G quincke spinal needle in the sitting position. At the end of the surgery, in ESPB group, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. At the postoperative 2, 4, 6, 12 and 24th hours, patients' rest, cough, movement, low back and headache VAS values, analgesic drug use, first analgesic use time and satisfaction were evaluated. ESPB spread level was evaluated with pin-prick at the 4-6th hours. The SPSS 11.5 program was used for statistical analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESPB | Active comparator | Other: Spinal anesthesia + bilateral erector spine plane blockSpinal anesthesia + bilateral ESPB (total of 40 ml, %0.5 bupivacaine) |
| Group SA | Active comparator | Other: Spinal anesthesiaOnly spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- between 18-45 years, pregnants delivered by CS from May 2020 to June 2021
Key exclusion criteria (1 listed)
- age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study
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 |
|---|---|---|
| Spinal anesthesia + bilateral erector spine plane blockIntraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. At the end of the surgery, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered. | Other | Group ESPB |
| Spinal anesthesiaIntraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered. | Other | Group SA |
Primary outcome
Postoperative pain
Time frame: 24 hours
VAS scores at 2, 4, 6, 12 and 24th hours. (VAS is an 11 point numeric scale ranges from 0 to 10. )
6 secondary outcomes
Postoperative analgesic drug consumption
Time frame: 24 hours
Need for rescue analgesic
Time frame: 24 hours
Number of patients with postoperative nausea-vomiting and need of antiemetic usage
Time frame: 24 hours
Patients' satisfaction
Time frame: 24 hours
First analgesic using time, first mobilization time, hospitalization time
Time frame: Postoperative 4 days on an average
ESPB spread level
Time frame: 4-6th hours
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 25 Jan 2023.
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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.
Bengi Şafak principal investigator
Ankara 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 Spinal anesthesia + bilateral erector spine plane block and Spinal anesthesia in people with Pain, Postoperative, run by Ankara 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 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 25 Jan 2023. 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?
Postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.