Pain, PostoperativeNCT05256953
Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery
A study testing Erector spina plane block + general anesthesia and Only general anesthesia in people with Pain, Postoperative, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Erector spina plane block + general anesthesia and Only general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2021to 1 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- ASA I , II patients
- BMI<35 kg/m2 (body weight <100 kg , >45 kg)
- Patients who underwent colorectal surgery
Who cannot join
- Patients who underwent abdominoperineal resection
- Patients who were evaluated as unsuccessful block in the dermatomal examination performed after the block was applied.
- Patients diagnosed with OSAS
- Pregnancy and breastfeeding
- Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- Hypersensitivity to local anesthetics or a history of allergy
Show all 12Show fewer
- Patients with a history of opioid use longer than four weeks
- Patients with severe psychiatric diseases such as psychosis or dementia that limit cooperation with the patient.
- Patients with anatomic deformity ( advanced scoliosis and kyphotic patients. Patients with pectus carinatum and pectus excavatum-like chest deformity )
- Patients who do not want to participate
- Patients who have had previous colorectal surgery, excluding diagnostic biopsies
- Patients who could not be reached by phone to inquire about their pain score at 3rd month.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery.
Read the detailed description
Colorectal surgery can be applied for many reasons, among these reasons, colorectal cancer (CRC) takes the first place. With the understanding of the pathophysiological effects of analgesics better, the use of regional techniques in providing analgesia for patients undergoing colorectal cancer surgery has come to the fore. Depending on the surgical procedure, pain faced by patients is an important problem that must be deal with in the postoperative period.
In this study, the hypothesis was determined as "Pre-operatively, erector spina plane block (ESPB) performed as part of multimodal analgesia reduces postoperative morphine consumption and pain scores."
The patients were divided into two groups :
Group ESP (erector spinae plan):
In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
Group GA (general anesthesia):
In this group, patients will be administered only IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
- Conditions
- Pain, Postoperative
- Being tested
- Erector spina plane block + general anesthesia, Only general anesthesia
- Keywords
- Regional anesthesia, Erector spinae plane block, Post-operative analgesia, Laparoscopy, Open surgery, Colorectal surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plane block + general anesthesiaProcedure or surgery
Also called Group ESP
Bilateral-injection ultrasound-guided bilateral erector spinae plane block
Pre-operatively, with the patient in the sitting position, 20ml 0.25% bupivacaine will be administered between the T9 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. The same procedure was applied bilaterally.
Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied.
Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.
Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day).
Only general anesthesiaProcedure or surgery
Also called Group GA
Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied.
Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.
Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Group ESP | Active comparator | bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA Receives: Procedure: Erector spina plane block + general anesthesia |
| Group GA | Active comparator | only IV morphine PCA Receives: Procedure: Only general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption in the first 24 hours
Morphine consumption in the first 24 hours were measured. Patients will be able to request opioids via a PCA device when their VAS score is above 3 at rest and during activity (coughing and deep breathing).
Measured: Postoperative day 1
Secondary outcomes (6)
Postoperative pain scores
Pain status at rest and while activity (coughing and deep breathing) were assessed by VAS scores at 0, 1, 3, 6, 12, 24 hours and 3th month after extubation. The VAS is an 11 point numeric scale which ranges from 0 to 10 at rest and during activity.
Measured: Postoperative month 3
The number of patient requiring rescue analgesia
The number of patients who required rescue analgesics were recorded at 0, 1, 3, 6, 12 and 24. hours after extubation
Measured: Postoperative day 1
Number of patients with postoperative nausea-vomiting and need of antiemetic usage
The severity of postoperative nausea and vomitting (PONV) was assessed using a descriptive verbal rating scale at 0, 1, 3, 6, 12 and 24 hours after extubation. If a score of 2 or more granisetron 1,5 mg iv will be administered. The PONV scale 0= no nausea, 1= slight nausea 2= moderate nausea, 3= vomiting once, 4= vomiting more than once
Measured: Postoperative day 1
Remifentanil consumption during the surgery
The total amount of remifentanil consumed will be recorded.
Measured: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min]
Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time
Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time were recorded
Measured: Postoperative 7 days on an average
Incidence of pruitus
Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start25 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Burcu Ustun, Ondokuz Mayıs University
- Investigators
- Yasemin Burcu Üstün, Prof, Study director, Ondokuz Mayıs University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256953
- Sponsor's protocol ID
- CRCESP140619
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
PubMed 33403545Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.
PubMed 30868029Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
PubMed 28919152Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.
PubMed 32357842
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05256953
- Acronym / sponsor ID
- CRCESP140619
- Conditions
- Pain, Postoperative
- Keywords
- Regional anesthesia, Erector spinae plane block, Post-operative analgesia, Laparoscopy, Open surgery, Colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 Feb 2022 (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 this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery.
Detailed description
Colorectal surgery can be applied for many reasons, among these reasons, colorectal cancer (CRC) takes the first place. With the understanding of the pathophysiological effects of analgesics better, the use of regional techniques in providing analgesia for patients undergoing colorectal cancer surgery has come to the fore. Depending on the surgical procedure, pain faced by patients is an important problem that must be deal with in the postoperative period.
In this study, the hypothesis was determined as "Pre-operatively, erector spina plane block (ESPB) performed as part of multimodal analgesia reduces postoperative morphine consumption and pain scores."
The patients were divided into two groups :
Group ESP (erector spinae plan):
In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
Group GA (general anesthesia):
In this group, patients will be administered only IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.
| Arm | Type | Receives |
|---|---|---|
| Group ESP | Active comparator | Procedure: Erector spina plane block + general anesthesiabilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA |
| Group GA | Active comparator | Procedure: Only general anesthesiaonly IV morphine PCA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 65 years
- ASA I , II patients
- BMI<35 kg/m2 (body weight <100 kg , >45 kg)
- Patients who underwent colorectal surgery
Key exclusion criteria (12 listed)
- Patients who underwent abdominoperineal resection
- Patients who were evaluated as unsuccessful block in the dermatomal examination performed after the block was applied.
- Patients diagnosed with OSAS
- Pregnancy and breastfeeding
- Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
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 spina plane block + general anesthesiaAlso: Group ESPBilateral-injection ultrasound-guided bilateral erector spinae plane block Pre-operatively, with the patient in the sitting position, 20ml 0.25% bupivacaine will be administered between the T9 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. The same procedure was applied bilaterally. Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied. Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose. Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day). | Procedure or surgery | Group ESP |
| Only general anesthesiaAlso: Group GAIntraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied. Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose. Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day). | Procedure or surgery | Group GA |
Primary outcome
Postoperative morphine consumption in the first 24 hours
Time frame: Postoperative day 1
Morphine consumption in the first 24 hours were measured. Patients will be able to request opioids via a PCA device when their VAS score is above 3 at rest and during activity (coughing and deep breathing).
6 secondary outcomes
Postoperative pain scores
Time frame: Postoperative month 3
The number of patient requiring rescue analgesia
Time frame: Postoperative day 1
Number of patients with postoperative nausea-vomiting and need of antiemetic usage
Time frame: Postoperative day 1
Remifentanil consumption during the surgery
Time frame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min]
Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time
Time frame: Postoperative 7 days on an average
Incidence of pruitus
Time frame: Postoperative day 1
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 25 Feb 2022.
- Background: PubMed 33403545Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Background: PubMed 30868029Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.
- Background: PubMed 28919152Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
- Background: PubMed 32357842Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.
- 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.
Yasemin Burcu Üstün, Prof study director
Ondokuz Mayıs University Faculty of Medicine
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 spina plane block + general anesthesia and Only general anesthesia in people with Pain, Postoperative, run by Ondokuz Mayıs 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 4 inclusion and 12 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 25 Feb 2022. 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 morphine consumption in the first 24 hours (time frame: Postoperative day 1). 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 NCT05256953, which also lists 4 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 25 Feb 2022.