Postoperative PainNCT06663449
Comparison of ESP Block and STAP Plane Block
A study testing subcostal transversus abdominis plane block and erector spinae plane block in people with Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- subcostal transversus abdominis plane block and erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 1 Jun 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo laparoscopic cholecystectomy:
- 18-75 years old
- ASA I-II-III patients
Who cannot join
- Use of anticoagulant drugs
- Known allergy to drugs to be used
- Infection in the area where the block will be performed
- Patient's reluctance
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
Kocaeli University
Kocaeli
Sevim Cesur, MD, +902623038248
About this study
Official title: Comparison of ESP Block and STAP Plane Block in Laparoscopic Cholecystectomy Surgery
In order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. In the group planned to undergo erector spinae plane block, erector spinae plane block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. In patients who will undergo subcostal transversus abdominis plane block, subcostal tap block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. The patients' perioperative pain will be monitored with NOL (nociception level) monitor. Remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this process will be compared. In this way, it is aimed to show that the analgesic method can be used effectively in the follow-up of pain management by comparing the Erector Spina Plane block and the Subcostal Transversus Abdominis Plane block as an effective analgesic application in laparoscopic cholecystectomy operations.
- Conditions
- Postoperative Pain
- Being tested
- subcostal transversus abdominis plane block, erector spinae plane block
- Keywords
- regional anesthesia, Erector spinae plane block, subcostal transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcostal transversus abdominis plane blockProcedure or surgery
subcostal transversus abdominis plane block will be performed using 20 mL of 0.25 bupivacaine
erector spinae plane blockProcedure or surgery
erector spinae plane block will be performed using 20 mL of 0.25 bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| GROUP USING subcostal transversus abdominis plane block | Active comparator | Before being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then subcostal tap block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this period will be compared. Receives: Procedure: subcostal transversus abdominis plane block |
| GROUP USING erector spinae plane block | Active comparator | Before being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then erector spinae plane block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this period will be compared. Receives: Procedure: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS Scores
NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)
Measured: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
Morphine consumption
Amount of morphine consumption (mg)
Measured: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Cesur, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663449
- Sponsor's protocol ID
- KAEK/13.bI.04
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashemi SJ, Heydari SM, Hashemi ST. Paravertebral block using bupivacaine with/without fentanyl on postoperative pain after laparoscopic cholecystectomy: A double-blind, randomized, control trial. Adv Biomed Res. 2014 Sep 4;3:187. doi: 10.4103/2277-9175.140099. eCollection 2014.
PubMed 25250301Agarwal A, Batra RK, Chhabra A, Subramaniam R, Misra MC. The evaluation of efficacy and safety of paravertebral block for perioperative analgesia in patients undergoing laparoscopic cholecystectomy. Saudi J Anaesth. 2012 Oct-Dec;6(4):344-9. doi: 10.4103/1658-354X.105860.
PubMed 23493523Mimic A, Bantel C, Jovicic J, Mimic B, Kisic-Tepavcevic D, Durutovic O, Ladjevic N. Psychological factors as predictors of early postoperative pain after open nephrectomy. J Pain Res. 2018 May 9;11:955-966. doi: 10.2147/JPR.S152282. eCollection 2018.
PubMed 29785136Vrsajkov V, Ilic N, Uvelin A, Ilic R, Lukic-Sarkanovic M, Plecas-Duric A. Erector spinae plane block reduces pain after laparoscopic cholecystectomy. Anaesthesist. 2021 Dec;70(Suppl 1):48-52. doi: 10.1007/s00101-021-01015-5. Epub 2021 Oct 18.
PubMed 34661682Kim S, Bang S, Kwon W. Intermittent erector spinae plane block as a part of multimodal analgesia after open nephrectomy. Chin Med J (Engl). 2019 Jun 20;132(12):1507-1508. doi: 10.1097/CM9.0000000000000269. No abstract available.
PubMed 31205117Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
PubMed 29670771Grass JA. Patient-controlled analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S44-S61. doi: 10.1213/01.ANE.0000177102.11682.20.
PubMed 16334492
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ESP Block and STAP Plane Block in Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06663449
- Acronym / sponsor ID
- KAEK/13.bI.04
- Conditions
- Postoperative Pain
- Keywords
- regional anesthesia, Erector spinae plane block, subcostal transversus abdominis plane block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Oct 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 order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. In the group planned to undergo erector spinae plane block, erector spinae plane block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. In patients who will undergo subcostal transversus abdominis plane block, subcostal tap block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. The patients' perioperative pain will be monitored with NOL (nociception level) monitor. Remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this process will be compared. In this way, it is aimed to show that the analgesic method can be used effectively in the follow-up of pain management by comparing the Erector Spina Plane block and the Subcostal Transversus Abdominis Plane block as an effective analgesic application in laparoscopic cholecystectomy operations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP USING subcostal transversus abdominis plane block | Active comparator | Procedure: subcostal transversus abdominis plane blockBefore being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then subcostal tap block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this period will be compared. |
| GROUP USING erector spinae plane block | Active comparator | Procedure: erector spinae plane blockBefore being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then erector spinae plane block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this period will be compared. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will undergo laparoscopic cholecystectomy:
- 18-75 years old
- ASA I-II-III patients
Key exclusion criteria (4 listed)
- Use of anticoagulant drugs
- Known allergy to drugs to be used
- Infection in the area where the block will be performed
- Patient's reluctance
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 |
|---|---|---|
| subcostal transversus abdominis plane blocksubcostal transversus abdominis plane block will be performed using 20 mL of 0.25 bupivacaine | Procedure or surgery | GROUP USING subcostal transversus abdominis plane block |
| erector spinae plane blockerector spinae plane block will be performed using 20 mL of 0.25 bupivacaine | Procedure or surgery | GROUP USING erector spinae plane block |
Primary outcome
NRS Scores
Time frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)
Morphine consumption
Time frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
Amount of morphine consumption (mg)
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 5 Dec 2024.
- Results publication: PubMed 25250301Hashemi SJ, Heydari SM, Hashemi ST. Paravertebral block using bupivacaine with/without fentanyl on postoperative pain after laparoscopic cholecystectomy: A double-blind, randomized, control trial. Adv Biomed Res. 2014 Sep 4;3:187. doi: 10.4103/2277-9175.140099. eCollection 2014.
- Results publication: PubMed 23493523Agarwal A, Batra RK, Chhabra A, Subramaniam R, Misra MC. The evaluation of efficacy and safety of paravertebral block for perioperative analgesia in patients undergoing laparoscopic cholecystectomy. Saudi J Anaesth. 2012 Oct-Dec;6(4):344-9. doi: 10.4103/1658-354X.105860.
- Results publication: PubMed 29785136Mimic A, Bantel C, Jovicic J, Mimic B, Kisic-Tepavcevic D, Durutovic O, Ladjevic N. Psychological factors as predictors of early postoperative pain after open nephrectomy. J Pain Res. 2018 May 9;11:955-966. doi: 10.2147/JPR.S152282. eCollection 2018.
- Results publication: PubMed 34661682Vrsajkov V, Ilic N, Uvelin A, Ilic R, Lukic-Sarkanovic M, Plecas-Duric A. Erector spinae plane block reduces pain after laparoscopic cholecystectomy. Anaesthesist. 2021 Dec;70(Suppl 1):48-52. doi: 10.1007/s00101-021-01015-5. Epub 2021 Oct 18.
- Results publication: PubMed 31205117Kim S, Bang S, Kwon W. Intermittent erector spinae plane block as a part of multimodal analgesia after open nephrectomy. Chin Med J (Engl). 2019 Jun 20;132(12):1507-1508. doi: 10.1097/CM9.0000000000000269. No abstract available.
- Results publication: PubMed 29670771Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
- Results publication: PubMed 16334492Grass JA. Patient-controlled analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S44-S61. doi: 10.1213/01.ANE.0000177102.11682.20.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcostal transversus abdominis plane block and erector spinae plane block in people with Postoperative Pain, run by Kocaeli 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 3 inclusion and 4 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 5 Dec 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?
Contact sevim Cesur Okan (0 541 911 41 00, svmcsr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS Scores (time frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)). 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 NCT06663449, which also lists 7 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 5 Dec 2024.