Pain ManagementESPBNCT06028100
Sacral Erector Spinae Plane Block(ESPB) in Lumbar Discectomy
A study testing sacral erector spinae plane block in people with Pain Management, run by Bilge Olgun Keles at 1 site in Turkey (Türkiye).
Trial summary
Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would be effective in lumbar discectomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- sacral erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age,
- American Society of Anesthesiology(ASA) status 1-3 group
Who cannot join
- Patients who refused to participate in the study
- Patients with known neuromuscular and haematological diseases
- Allergy to local anaesthetics
- Contraindications to regional anaesthesia
- Anatomical changes in the lumbo-sacral region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Research and Training Hospital
Merkez, Giresun, 28100
About this study
Official title: The Effect of an Ultrasound-guided Sacral Erector Spinae Plane Block on the Post-operative Pain of Lumbar Discectomy Surgery
Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would be effective in lumbar discectomies. The investigators wanted to look at the effects of sacral erector spinae plane block on postoperative pain and opioid consumption in lumbar discectomy operations. There is no randomised controlled study on sacral espb in the literature. The researchers think that the results of the study are promising. Sacral espb is an easy-to-administer block with a low risk of complications and can be used effectively in lumbar discectomy analgesia.
Read the detailed description
This prospective, randomised, controlled, double-blind, single-centre study was approved by our Ethics Committee (KAEK2023/06). The investigators followed the Consolidated Reporting Trials Standards (CONSORT). It was conducted in patients undergoing elective lumbar discectomy, and informed consent was obtained from the patients. They were randomised using a closed envelope technique, opened by the physician performing the block. 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up. The patients were unaware that the block was being performed on them. A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.
Standard monitoring (peripheral oxygen saturation, electrocardiogram, non-invasive arterial blood pressure monitoring) was performed. Anaesthesia induction was achieved with 1 mcg/kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium, and anaesthesia maintenance with 2% sevoflurane, 4 lt/min 50%/50% oxygen/nitrogen mixture. Both groups received 1 g IV paracetamol towards the end of surgery. The patients were extubated after 2 mg/kg of sugammadex and were transferred to the recovery room.
The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side.
All patient demographics, age, weight, and duration of surgery, post-operative VAS scores, blood pressure, heart rate and oxygen saturation values at 30 min, 1, 6, 12 and 24 hours, total tramadol consumption, rescue analgesic use, time of first rescue analgesic requirement, patient satisfaction and side effects were recorded.
The Shapiro-Wilk test was used to examine the normality of quantitative data. Comparison of normally distributed data was performed by independent samples t-test, and comparison of non-normally distributed data was performed by Mann-Whitney U test. Comparison of qualitative data was performed using the Pearson chi-squared test. Data were presented as mean ± standard deviation, median (minimum - maximum) and n (%). Statistical significance was accepted as p<0.05. In a previous study (9), the power analysis performed to detect a difference of 15.4 mg between the 48-hour opioid consumption values of the two groups (p<0.05) was calculated with 90% power and an effect size of 0.96, and the required sample size was determined to be 24 for each group. If 10-15% of patients were excluded from the study, 27 patients were included for each group and 54 patients in total.
- Conditions
- Pain Management
- Being tested
- sacral erector spinae plane block
- Keywords
- regional block, erector spinae plane block, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral erector spinae plane blockProcedure or surgery
espb from bilateral sacral level 2 with 20 ml %0,25 bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| espb group | Active comparator | The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side Receives: Procedure: sacral erector spinae plane block |
| control group | No intervention | The second group had no any block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain scores
Visual Analog Scala (0:No pain 10: Worst pain possible)
Measured: 24 hours
Patient total opioid consumption
The number of patient controlled analgesia device boluses doses
Measured: 24 hours
Secondary outcomes (2)
Nausea-vomiting
The incidence of side effects described yes or no
Measured: 24 hours
Patient satisfaction
Patient satisfaction (0:Not satisfied 10:Very satisfied)
Measured: 24. hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Jun 2023
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Model description
- 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up.A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.And total consumption of analgesic and rescue analgesics were recorded.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilge Olgun Keles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bilge Olgun Keles, Giresun University
- Investigators
- Bilge Olgun Keleş, M.D., Study director, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028100
- Sponsor's protocol ID
- 2023/06
- Acronym
- ESPB
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since it is the first study on this subject in the literature
Publications
Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
PubMed 30853517Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.
PubMed 26288544Kilicaslan A, Aydin A, Kekec AF, Ahiskalioglu A. Sacral erector spinae plane block provides effective postoperative analgesia for pelvic and sacral fracture surgery. J Clin Anesth. 2020 May;61:109674. doi: 10.1016/j.jclinane.2019.109674. Epub 2019 Dec 4. No abstract available.
PubMed 31812367Chakraborty A, Chakraborty S, Sen S, Bhatacharya T, Khemka R. Modification of the sacral erector spinae plane block using an ultrasound-guided sacral foramen injection: dermatomal distribution and radiocontrast study. Anaesthesia. 2021 Nov;76(11):1538-1539. doi: 10.1111/anae.15549. Epub 2021 Jul 26. No abstract available.
PubMed 34309009Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.
PubMed 35431750
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Ultrasound-guided Sacral Erector Spinae Plane Block on the Post-operative Pain of Lumbar Discectomy Surgery
- ClinicalTrials.gov ID
- NCT06028100
- Acronym / sponsor ID
- ESPB / 2023/06
- Conditions
- Pain Management
- Keywords
- regional block, erector spinae plane block, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bilge Olgun KelesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Sep 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.
Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would be effective in lumbar discectomies. The investigators wanted to look at the effects of sacral erector spinae plane block on postoperative pain and opioid consumption in lumbar discectomy operations. There is no randomised controlled study on sacral espb in the literature. The researchers think that the results of the study are promising. Sacral espb is an easy-to-administer block with a low risk of complications and can be used effectively in lumbar discectomy analgesia.
Detailed description
This prospective, randomised, controlled, double-blind, single-centre study was approved by our Ethics Committee (KAEK2023/06). The investigators followed the Consolidated Reporting Trials Standards (CONSORT). It was conducted in patients undergoing elective lumbar discectomy, and informed consent was obtained from the patients. They were randomised using a closed envelope technique, opened by the physician performing the block. 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up. The patients were unaware that the block was being performed on them. A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.
Standard monitoring (peripheral oxygen saturation, electrocardiogram, non-invasive arterial blood pressure monitoring) was performed. Anaesthesia induction was achieved with 1 mcg/kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium, and anaesthesia maintenance with 2% sevoflurane, 4 lt/min 50%/50% oxygen/nitrogen mixture. Both groups received 1 g IV paracetamol towards the end of surgery. The patients were extubated after 2 mg/kg of sugammadex and were transferred to the recovery room.
The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side.
All patient demographics, age, weight, and duration of surgery, post-operative VAS scores, blood pressure, heart rate and oxygen saturation values at 30 min, 1, 6, 12 and 24 hours, total tramadol consumption, rescue analgesic use, time of first rescue analgesic requirement, patient satisfaction and side effects were recorded.
The Shapiro-Wilk test was used to examine the normality of quantitative data. Comparison of normally distributed data was performed by independent samples t-test, and comparison of non-normally distributed data was performed by Mann-Whitney U test. Comparison of qualitative data was performed using the Pearson chi-squared test. Data were presented as mean ± standard deviation, median (minimum - maximum) and n (%). Statistical significance was accepted as p<0.05. In a previous study (9), the power analysis performed to detect a difference of 15.4 mg between the 48-hour opioid consumption values of the two groups (p<0.05) was calculated with 90% power and an effect size of 0.96, and the required sample size was determined to be 24 for each group. If 10-15% of patients were excluded from the study, 27 patients were included for each group and 54 patients in total.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up.A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.And total consumption of analgesic and rescue analgesics were recorded.
| Arm | Type | Receives |
|---|---|---|
| espb group | Active comparator | Procedure: sacral erector spinae plane blockThe first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side |
| control group | No intervention | –The second group had no any block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years of age,
- American Society of Anesthesiology(ASA) status 1-3 group
Key exclusion criteria (5 listed)
- Patients who refused to participate in the study
- Patients with known neuromuscular and haematological diseases
- Allergy to local anaesthetics
- Contraindications to regional anaesthesia
- Anatomical changes in the lumbo-sacral region
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 |
|---|---|---|
| sacral erector spinae plane blockespb from bilateral sacral level 2 with 20 ml %0,25 bupivacaine | Procedure or surgery | espb group |
Primary outcome
Patient pain scores
Time frame: 24 hours
Visual Analog Scala (0:No pain 10: Worst pain possible)
Patient total opioid consumption
Time frame: 24 hours
The number of patient controlled analgesia device boluses doses
2 secondary outcomes
Nausea-vomiting
Time frame: 24 hours
Patient satisfaction
Time frame: 24. 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 11 Sep 2023.
- Results publication: PubMed 30853517Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
- Results publication: PubMed 26288544Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.
- Results publication: PubMed 31812367Kilicaslan A, Aydin A, Kekec AF, Ahiskalioglu A. Sacral erector spinae plane block provides effective postoperative analgesia for pelvic and sacral fracture surgery. J Clin Anesth. 2020 May;61:109674. doi: 10.1016/j.jclinane.2019.109674. Epub 2019 Dec 4. No abstract available.
- Results publication: PubMed 34309009Chakraborty A, Chakraborty S, Sen S, Bhatacharya T, Khemka R. Modification of the sacral erector spinae plane block using an ultrasound-guided sacral foramen injection: dermatomal distribution and radiocontrast study. Anaesthesia. 2021 Nov;76(11):1538-1539. doi: 10.1111/anae.15549. Epub 2021 Jul 26. No abstract available.
- Results publication: PubMed 35431750Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.
- Individual participant dataSharing planned: No. Since it is the first study on this subject in the literature
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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.
Bilge Olgun Keleş, M.D. study director
Giresun 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 sacral erector spinae plane block in people with Pain Management, run by Bilge Olgun Keles 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 2 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 11 Sep 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?
Patient pain scores (time frame: 24 hours). The study lists 2 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 NCT06028100, which also lists 5 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 11 Sep 2023.