Lumbar Spinal StenosisESPNCT06567964
Ultrasound-guided ESP Block vs. Wound Infiltration in Lumbar Surgery: A Comparative Analysis (ESP:Erector Spinae Plane)
A study testing Erector Spinae Plane Block(ESPB) and Wound infiltration in people with Lumbar Spinal Stenosis and Lumbar Spine Instability, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Spine Instability, Lumbar Spine Degeneration
- What is being tested?
- Erector Spinae Plane Block(ESPB) and Wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Jun 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective lumbar spine surgery involving instrumentation
- ASA physical status I-III
- Ability to provide informed consent
Who cannot join
- Known allergies to local anesthetics
- Coagulopathy or anticoagulant therapy
- Infection at the injection site
- Preexisting neurological disorders affecting sensory perception
- Pregnancy
- Inability to understand the visual analog scale (VAS) for pain assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Wound Infiltration for Postoperative Analgesia in Instrumented Lumbar Spinal Surgeries
This study aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation.
Read the detailed description
In this randomized controlled trial, 80 patients were divided into two groups: ESPB (n=40) and WI (n=40). Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at multiple time points within 24 hours. Additionally, opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting (PONV), and patient satisfaction were evaluated.
- Being tested
- Erector Spinae Plane Block(ESPB), Wound infiltration
- Keywords
- Erector Spinae Plane Block, Wound Infiltration, Postoperative Analgesia, Lumbar Spinal Surgery, Ultrasound-Guided Anesthesia, Postoperative Pain, Visual Analog Scale (VAS), Enhanced Recovery After Surgery (ERAS)
- Medical subject headings
- Spinal Stenosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block(ESPB)Procedure or surgery
ESPB was administered preoperatively under ultrasound guidance via a high-frequency linear probe (Sonosite M-Turbo, Fujifilm Sonosite Inc., USA) (Figure 1). The procedure was as follows:
- Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost.
- Ultrasound Setup: A high-frequency linear ultrasound probe was placed in a parasagittal orientation over the transverse process of the lumbar vertebra at the level of surgery.
- Needle Insertion: After skin disinfection with chlorhexidine, a 22-gauge, 100-mm needle (Stimuplex A, B. Braun Melsungen AG, Germany) was inserted in-plane to the ultrasound probe. The needle was advanced until the tip contacted the transverse process.
- Injection: Following negative aspiration to ensure no vascular puncture, 20 mL of 0.5% bupivacaine was injected incrementally, with real-time ultrasound visualization to confirm the correct spread of the anesthetic solution.
Wound infiltrationProcedure or surgery
Wound infiltration was performed by the surgeon at the end of the surgery via the following procedure:
- Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe.
- For infiltration, the anesthetic mixture was infiltrated into multiple layers of the surgical wound. This included the subcutaneous tissue and muscle layers, ensuring the even distribution of the anesthetic solution to cover the entire surgical area.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (Group E) | Active comparator | ESPB was administered preoperatively under ultrasound guidance via a high-frequency linear probe (Sonosite M-Turbo, Fujifilm Sonosite Inc., USA) (Figure 1). The procedure was as follows:
1. Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost.
2. Ultrasound Setup: A high-frequency linear ultrasound probe was placed in a parasagittal orientation over the transverse process of the lumbar vertebra at the level of surgery.
3. Needle Insertion: After skin disinfection with chlorhexidine, a 22-gauge, 100-mm needle (Stimuplex A, B. Braun Melsungen AG, Germany) was inserted in-plane to the ultrasound probe. The needle was advanced until the tip contacted the transverse process.
4. Injection: Following negative aspiration to ensure no vascular puncture, 20 mL of 0.5% bupivacaine was injected incrementally, with real-time ultrasound visualization to confirm the correct spread of the anesthetic solution. Receives: Procedure: Erector Spinae Plane Block(ESPB) |
| Wound infiltration (Group WI) | Active comparator | Wound infiltration was performed by the surgeon at the end of the surgery via the following procedure:
1. Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe.
2. For infiltration, the anesthetic mixture was infiltrated into multiple layers of the surgical wound. This included the subcutaneous tissue and muscle layers, ensuring the even distribution of the anesthetic solution to cover the entire surgical area. Receives: Procedure: Wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
The pain intensity was assessed via the visual analog scale (VAS).The VAS is a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 1., 6., 12., 24., and 48. hours postoperatively
Secondary outcomes (4)
Total Opioid Consumption
Recorded as morphine equivalents
Measured: In the first 48 hours postoperatively
Time to first request for rescue analgesia
Noted in hours postoperatively
Measured: Noted in hours in the first 48 hours postoperatively
Incidence of Side Effects
Including nausea, vomiting, pruritus, and urinary retention,
Measured: Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively
Patient Satisfaction with Pain Management
Patient satisfaction was assessed via a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied)
Measured: At 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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 Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Model description
- Participants Eligible participants were adults aged 18-70 years who were scheduled for elective lumbar spinal surgery with instrumentation. The inclusion criteria were as follows: * Elective lumbar spine surgery involving instrumentation * ASA physical status I-III * Ability to provide informed consent The exclusion criteria were as follows: * Known allergies to local anesthetics * Coagulopathy or anticoagulant therapy * Infection at the injection site * Preexisting neurological disorders affecting sensory perception * Pregnancy * Inability to understand the visual analog scale (VAS) for pain assessment The participants were randomly allocated into one of two groups: the ESPB group (Group E) or the WI group (Group W).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YÜCEL YÜCE, Saglik Bilimleri Universitesi
- Investigators
- Yücel Yüce, MD,Assoc Prf, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567964
- Sponsor's protocol ID
- SaglikBilimleriU-KLKSH-Anes-02
- Acronym
- ESP
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuce Y, Karakus SA, Simsek T, Onal C, Sezen O, Cevik B, Aydogmus E. Comparative efficacy of ultrasound-guided erector spinae plane block versus wound infiltration for postoperative analgesia in instrumented lumbar spinal surgeries. BMC Anesthesiol. 2024 Oct 15;24(1):374. doi: 10.1186/s12871-024-02754-9.
PubMed 39407122
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Wound Infiltration for Postoperative Analgesia in Instrumented Lumbar Spinal Surgeries
- ClinicalTrials.gov ID
- NCT06567964
- Acronym / sponsor ID
- ESP / SaglikBilimleriU-KLKSH-Anes-02
- Keywords
- Erector Spinae Plane Block, Wound Infiltration, Postoperative Analgesia, Lumbar Spinal Surgery, Ultrasound-Guided Anesthesia, Postoperative Pain, Visual Analog Scale (VAS), Enhanced Recovery After Surgery (ERAS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Aug 2024 (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 aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation.
Detailed description
In this randomized controlled trial, 80 patients were divided into two groups: ESPB (n=40) and WI (n=40). Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at multiple time points within 24 hours. Additionally, opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting (PONV), and patient satisfaction were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants Eligible participants were adults aged 18-70 years who were scheduled for elective lumbar spinal surgery with instrumentation. The inclusion criteria were as follows: * Elective lumbar spine surgery involving instrumentation * ASA physical status I-III * Ability to provide informed consent The exclusion criteria were as follows: * Known allergies to local anesthetics * Coagulopathy or anticoagulant therapy * Infection at the injection site * Preexisting neurological disorders affecting sensory perception * Pregnancy * Inability to understand the visual analog scale (VAS) for pain assessment The participants were randomly allocated into one of two groups: the ESPB group (Group E) or the WI group (Group W).
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (Group E) | Active comparator | Procedure: Erector Spinae Plane Block(ESPB)ESPB was administered preoperatively under ultrasound guidance via a high-frequency linear probe (Sonosite M-Turbo, Fujifilm Sonosite Inc., USA) (Figure 1). The procedure was as follows: 1. Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost. 2. Ultrasound Setup: A high-frequency linear ultrasound probe was placed in a parasagittal orientation over the transverse process of the lumbar vertebra at the level of surgery. 3. Needle Insertion: After skin disinfection with chlorhexidine, a 22-gauge, 100-mm needle (Stimuplex A, B. Braun Melsungen AG, Germany) was inserted in-plane to the ultrasound probe. The needle was advanced until the tip contacted the transverse process. 4. Injection: Following negative aspiration to ensure no vascular puncture, 20 mL of 0.5% bupivacaine was injected incrementally, with real-time ultrasound visualization to confirm the correct spread of the anesthetic solution. |
| Wound infiltration (Group WI) | Active comparator | Procedure: Wound infiltrationWound infiltration was performed by the surgeon at the end of the surgery via the following procedure: 1. Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe. 2. For infiltration, the anesthetic mixture was infiltrated into multiple layers of the surgical wound. This included the subcutaneous tissue and muscle layers, ensuring the even distribution of the anesthetic solution to cover the entire surgical area. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective lumbar spine surgery involving instrumentation
- ASA physical status I-III
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Known allergies to local anesthetics
- Coagulopathy or anticoagulant therapy
- Infection at the injection site
- Preexisting neurological disorders affecting sensory perception
- Pregnancy
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 Block(ESPB)ESPB was administered preoperatively under ultrasound guidance via a high-frequency linear probe (Sonosite M-Turbo, Fujifilm Sonosite Inc., USA) (Figure 1). The procedure was as follows: 1. Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost. 2. Ultrasound Setup: A high-frequency linear ultrasound probe was placed in a parasagittal orientation over the transverse process of the lumbar vertebra at the level of surgery. 3. Needle Insertion: After skin disinfection with chlorhexidine, a 22-gauge, 100-mm needle (Stimuplex A, B. Braun Melsungen AG, Germany) was inserted in-plane to the ultrasound probe. The needle was advanced until the tip contacted the transverse process. 4. Injection: Following negative aspiration to ensure no vascular puncture, 20 mL of 0.5% bupivacaine was injected incrementally, with real-time ultrasound visualization to confirm the correct spread of the anesthetic solution. | Procedure or surgery | Erector Spinae Plane Block (Group E) |
| Wound infiltrationWound infiltration was performed by the surgeon at the end of the surgery via the following procedure: 1. Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe. 2. For infiltration, the anesthetic mixture was infiltrated into multiple layers of the surgical wound. This included the subcutaneous tissue and muscle layers, ensuring the even distribution of the anesthetic solution to cover the entire surgical area. | Procedure or surgery | Wound infiltration (Group WI) |
Primary outcome
Postoperative pain intensity
Time frame: 1., 6., 12., 24., and 48. hours postoperatively
The pain intensity was assessed via the visual analog scale (VAS).The VAS is a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
4 secondary outcomes
Total Opioid Consumption
Time frame: In the first 48 hours postoperatively
Time to first request for rescue analgesia
Time frame: Noted in hours in the first 48 hours postoperatively
Incidence of Side Effects
Time frame: Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively
Patient Satisfaction with Pain Management
Time frame: At 48 hours postoperatively
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 23 Aug 2024.
- Derived from this study: PubMed 39407122Yuce Y, Karakus SA, Simsek T, Onal C, Sezen O, Cevik B, Aydogmus E. Comparative efficacy of ultrasound-guided erector spinae plane block versus wound infiltration for postoperative analgesia in instrumented lumbar spinal surgeries. BMC Anesthesiol. 2024 Oct 15;24(1):374. doi: 10.1186/s12871-024-02754-9.
- 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.
Yücel Yüce, MD,Assoc Prf principal investigator
Saglik Bilimleri Universitesi
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(ESPB) and Wound infiltration in people with Lumbar Spinal Stenosis and Lumbar Spine Instability, run by Saglik Bilimleri Universitesi 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 6 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 23 Aug 2024. 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 intensity (time frame: 1., 6., 12., 24., and 48. hours postoperatively). 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 NCT06567964, 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 23 Aug 2024.