Postoperative PainNCT04316416
Evaluation of Effectivity of Erector Spina Plane Block With Different Levels
A study testing T7 Level Erector Spinae Plane Block and T9 Level Erector Spinae Plane Block in people with Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- T7 Level Erector Spinae Plane Block and T9 Level Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2020to 2 Jun 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1-2 Elective cholecystectomy surgery
- 18-65 years old patients
Who cannot join
- ASA 3-4 patients
- Patient refusal
- several lung and heart disease
- Contraindications to regional anesthesia
- BMİ > 35 patients
- Known allergy to local anesthetics
Show all 10Show fewer
- Bleeding diathesis
- Use of any anti-coagulants
- Severe kidney or liver disease
- Patient with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, 34000
About this study
Official title: Evaluation of The Postoperative Analgesic Effectivity of Erector Spina Plane Block With Different Injection Levels on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.
Read the detailed description
Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.
- Conditions
- Postoperative Pain
- Being tested
- T7 Level Erector Spinae Plane Block, T9 Level Erector Spinae Plane Block, control group
- Keywords
- postoperative pain, erector spinae plane blok, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T7 Level Erector Spinae Plane BlockProcedure or surgery
ESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T7 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T7 spinous process.
After imaging of erector spina musceles and transvers process of 7 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge \& 8cm directed from cranial to caudal.
After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them.
Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded.
T9 Level Erector Spinae Plane BlockProcedure or surgery
ESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T9 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T9 spinous process.
After imaging of erector spina musceles and transvers process of 9 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge \& 8cm directed from cranial to caudal.
After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them.
Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded.
control groupDrug
24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.
| Study group | Role | What they receive |
|---|---|---|
| T7 Bilateral ESP block | Active comparator | Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging T7 (7th thoracal vertebrae ) transverse process accompanied by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed. Receives: Procedure: T7 Level Erector Spinae Plane Block |
| T9 bilateral ESP block | Active comparator | Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging transverse process T9 (9th thoracal vertebrae) by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed. Receives: Procedure: T9 Level Erector Spinae Plane Block |
| Control group | Placebo comparator | Postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard pain follow-up and monitorization will be performed. No block will be performed in this group. Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain change
It was planned to check the change in the NRS scores of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
Measured: up to 24 hours
Postoperative morphine consumption change
It was planned to check the change in the morphine consumption of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.
Measured: up to 24 hours
Secondary outcomes (2)
side effects
Rate of side-effect occurrences (such as rate of vomiting,nausea,shoulder pain) between groups will be compared.
Measured: up to 24 hours
number of blocked dermatome sites
number of blocked dermatome sites will be recorded.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start15 Feb 2020
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital
- Investigators
- SERPİL SEHİRLİOGLU, MD, Principal investigator, Gaziosmanpasa Research and Education HospitalAYFER KAYA GOK, MD, Study chair, Gaziosmanpasa Research and Education HospitalUMRAN YAMAN, MD, Study chair, Gaziosmanpasa Research and Education HospitalAYGEN U TURKMEN, MD, Study chair, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316416
- Sponsor's protocol ID
- GaziosmanpasaTREH18
- Status last verified
- Jun 2020
- First submitted
- 8 Mar 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altiparmak B, Toker MK, Uysal AI, Kuscu Y, Demirbilek SG. [Efficacy of ultrasound-guided erector spinae plane block for analgesia after laparoscopic cholecystectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):561-568. doi: 10.1016/j.bjan.2019.09.001. Epub 2019 Dec 9.
PubMed 31822353
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Postoperative Analgesic Effectivity of Erector Spina Plane Block With Different Injection Levels on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
- ClinicalTrials.gov ID
- NCT04316416
- Acronym / sponsor ID
- GaziosmanpasaTREH18
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, erector spinae plane blok, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 20 Mar 2020 (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 last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.
Detailed description
Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T7 Bilateral ESP block | Active comparator | Procedure: T7 Level Erector Spinae Plane BlockUltrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging T7 (7th thoracal vertebrae ) transverse process accompanied by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed. |
| T9 bilateral ESP block | Active comparator | Procedure: T9 Level Erector Spinae Plane BlockUltrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging transverse process T9 (9th thoracal vertebrae) by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed. |
| Control group | Placebo comparator | Drug: control groupPostoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard pain follow-up and monitorization will be performed. No block will be performed in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-2 Elective cholecystectomy surgery
- 18-65 years old patients
Key exclusion criteria (10 listed)
- ASA 3-4 patients
- Patient refusal
- several lung and heart disease
- Contraindications to regional anesthesia
- BMİ > 35 patients
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 |
|---|---|---|
| T7 Level Erector Spinae Plane BlockESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T7 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T7 spinous process. After imaging of erector spina musceles and transvers process of 7 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge \& 8cm directed from cranial to caudal. After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them. Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded. | Procedure or surgery | T7 Bilateral ESP block |
| T9 Level Erector Spinae Plane BlockESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T9 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T9 spinous process. After imaging of erector spina musceles and transvers process of 9 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge \& 8cm directed from cranial to caudal. After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them. Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded. | Procedure or surgery | T9 bilateral ESP block |
| control group24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine. | Drug | Control group |
Primary outcome
Postoperative pain change
Time frame: up to 24 hours
It was planned to check the change in the NRS scores of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels. A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
Postoperative morphine consumption change
Time frame: up to 24 hours
It was planned to check the change in the morphine consumption of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.
2 secondary outcomes
side effects
Time frame: up to 24 hours
number of blocked dermatome sites
Time frame: up to 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 4 Jun 2020.
- Background: PubMed 31822353Altiparmak B, Toker MK, Uysal AI, Kuscu Y, Demirbilek SG. [Efficacy of ultrasound-guided erector spinae plane block for analgesia after laparoscopic cholecystectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):561-568. doi: 10.1016/j.bjan.2019.09.001. Epub 2019 Dec 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.
SERPİL SEHİRLİOGLU, MD principal investigator
Gaziosmanpasa Research and Education Hospital
AYFER KAYA GOK, MD study chair
Gaziosmanpasa Research and Education Hospital
UMRAN YAMAN, MD study chair
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T7 Level Erector Spinae Plane Block and T9 Level Erector Spinae Plane Block in people with Postoperative Pain, run by Gaziosmanpasa Research and Education 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 2 inclusion and 10 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 4 Jun 2020. 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. Some participants in this study may receive a placebo. 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 change (time frame: up to 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 NCT04316416, 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 4 Jun 2020.