Postoperative PainNCT06693141
Effects of Erector Spinae Plane Block and Intrathecal Morphine Administration on Intraoperative Sevoflurane Consumption
An observational study of Postoperative Pain and Anesthesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study, the investigators aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Anesthesia
- What is being tested?
- ESP block and ITM
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 15 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients operated for single level and non-recurring lumbar disc herniation.
Who may be able to join
- Patients aged over 18 years
- Patients receiving general anesthesia
- Patients with an ASA score of I-II
- Patients undergoing elective surgery for single-level lumbar disc herniation
- Patients who provided informed consent after being informed
Who cannot join
- Patients who did not provide informed consent after being informed
- Patients over 65 years of age
- Patients with an ASA score of III or higher
- Patients with recurrent lumbar disc herniation (LDH)
- Patients undergoing surgery for multi-level LDH
- Patients with a body mass index (BMI) of 30 or higher
Show all 13Show fewer
- Patients with allergies to morphine or bupivacaine
- Patients with major cardiac, respiratory, hepatic, renal, neurological, or psychiatric diseases
- Patients with a history of alcohol or substance abuse
- Patients with a local infection at the injection site
- Patients with bleeding diathesis
- Patients with a history of anticoagulant medication use
- Patients with contraindications to spinal or regional anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
About this study
Official title: Comparison of the Effects of Erector Spinae Plane Block and Intrathecal Morphine Administration on Intraoperative Sevoflurane Consumption in Disc Surgeries
In our study, the investigators aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.
Read the detailed description
The amount of volatile anesthetic agents used for anesthesia maintenance can be significantly reduced with potent and long-acting analgesic interventions administered during the preoperative period. Such interventions enable the maintenance of anesthesia with more optimal levels of agents during surgery, providing significant advantages in terms of both patient safety and cost.
Studies have recommended multimodal analgesia approaches involving the Erector Spinae Plane (ESP) block and intrathecal morphine (ITM) injection for various surgical procedures. These two methods, through different mechanisms of action, not only reduce intraoperative anesthetic agent consumption but also play a critical role in postoperative pain management. Although studies have investigated the effects of ESP block and ITM injection on intraoperative volatile anesthetic consumption, there is limited research directly comparing their impacts on volatile anesthetic consumption and postoperative analgesic requirements.
In our study, we aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.
- Conditions
- Postoperative Pain, Anesthesia
- Being tested
- ESP block, ITM
- Keywords
- Erector Spinae Plane block, Intrathecal morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockOther
ESP block was applied to the patients.
ITMOther
ITM was applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| ESP | ESP block was applied to patients in this group in the preoperative period. Receives: Other: ESP block | |
| ITM | Intrathecal morphine was applied to patients in this group in the preoperative period. Receives: Other: ITM | |
| Control | Patients who did not undergo ESP block or ITM were included in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Sevoflurane consumption
End-expiratory sevoflurane concentration was monitored every 5 minutes for 60 minutes. The mean sevoflurane concentration in the first 60 minutes was calculated.
Measured: 60 minutes after anesthesia induction
Secondary outcomes (5)
Rescue analgesic consumption
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
Measured: 2 hours postoperatively
Rescue analgesic consumption
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
Measured: 4 hours postoperatively
Rescue analgesic consumption
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
Measured: 8 hours postoperatively
Rescue analgesic consumption
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
Measured: 12 hours postoperatively
Rescue analgesic consumption
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693141
- Sponsor's protocol ID
- Bengü Tez
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 33751203Lal A, Singh MK, Kanaujia SK, Mishra NK, Singh BP, Singh GP. Comparison of Intrathecal Morphine Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Lumbar Spine Surgery: A Randomized Control Trial. Cureus. 2024 Jul 17;16(7):e64775. doi: 10.7759/cureus.64775. eCollection 2024 Jul.
PubMed 39156461Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.
PubMed 37886866
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Erector Spinae Plane Block and Intrathecal Morphine Administration on Intraoperative Sevoflurane Consumption in Disc Surgeries
- ClinicalTrials.gov ID
- NCT06693141
- Acronym / sponsor ID
- Bengü Tez
- Conditions
- Postoperative Pain, Anesthesia
- Keywords
- Erector Spinae Plane block, Intrathecal morphine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 18 Nov 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.
In our study, the investigators aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.
Detailed description
The amount of volatile anesthetic agents used for anesthesia maintenance can be significantly reduced with potent and long-acting analgesic interventions administered during the preoperative period. Such interventions enable the maintenance of anesthesia with more optimal levels of agents during surgery, providing significant advantages in terms of both patient safety and cost.
Studies have recommended multimodal analgesia approaches involving the Erector Spinae Plane (ESP) block and intrathecal morphine (ITM) injection for various surgical procedures. These two methods, through different mechanisms of action, not only reduce intraoperative anesthetic agent consumption but also play a critical role in postoperative pain management. Although studies have investigated the effects of ESP block and ITM injection on intraoperative volatile anesthetic consumption, there is limited research directly comparing their impacts on volatile anesthetic consumption and postoperative analgesic requirements.
In our study, we aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESP | – | Other: ESP blockESP block was applied to patients in this group in the preoperative period. |
| ITM | – | Other: ITMIntrathecal morphine was applied to patients in this group in the preoperative period. |
| Control | – | –Patients who did not undergo ESP block or ITM were included in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients operated for single level and non-recurring lumbar disc herniation.
Key inclusion criteria (5 listed)
- Patients aged over 18 years
- Patients receiving general anesthesia
- Patients with an ASA score of I-II
- Patients undergoing elective surgery for single-level lumbar disc herniation
- Patients who provided informed consent after being informed
Key exclusion criteria (13 listed)
- Patients who did not provide informed consent after being informed
- Patients over 65 years of age
- Patients with an ASA score of III or higher
- Patients with recurrent lumbar disc herniation (LDH)
- Patients undergoing surgery for multi-level LDH
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 |
|---|---|---|
| ESP blockESP block was applied to the patients. | Other | ESP |
| ITMITM was applied to the patients. | Other | ITM |
Primary outcome
Intraoperative Sevoflurane consumption
Time frame: 60 minutes after anesthesia induction
End-expiratory sevoflurane concentration was monitored every 5 minutes for 60 minutes. The mean sevoflurane concentration in the first 60 minutes was calculated.
5 secondary outcomes
Rescue analgesic consumption
Time frame: 2 hours postoperatively
Rescue analgesic consumption
Time frame: 4 hours postoperatively
Rescue analgesic consumption
Time frame: 8 hours postoperatively
Rescue analgesic consumption
Time frame: 12 hours postoperatively
Rescue analgesic consumption
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: 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.
- Background: PubMed 39156461Lal A, Singh MK, Kanaujia SK, Mishra NK, Singh BP, Singh GP. Comparison of Intrathecal Morphine Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Lumbar Spine Surgery: A Randomized Control Trial. Cureus. 2024 Jul 17;16(7):e64775. doi: 10.7759/cureus.64775. eCollection 2024 Jul.
- Results publication: PubMed 37886866Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Anesthesia, run by Ankara Etlik City 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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 19 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Intraoperative Sevoflurane consumption (time frame: 60 minutes after anesthesia induction). 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 NCT06693141, 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 19 Nov 2024.