AnalgesiaNCT04648345
Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy
A study testing Erector spinal plane block in people with Analgesia, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）. Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Erector spinal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to 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
- American Society of Anesthesiologists (ASA) physical status 1-3
- Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia
Who cannot join
- patient refusal
- pregnancy
- history of allergy to study drugs
- neurological and cognitive disorders
- coagulopathy
- chronic pain disorders
- infections at the injection site
- history of abdominal surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blind，Controlled Clinical Trial.
Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）.
Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.
- Conditions
- Analgesia
- Being tested
- Erector spinal plane block
- Keywords
- erector spinal plane block, analgesia, laparoscopic cholecystectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinal plane blockProcedure or surgery
Also called Vertebral side block, Local block
After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinal plane block group (ESPB group) | Experimental | After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Receives: Procedure: Erector spinal plane block |
| Vertebral side block group (VSB group) | Active comparator | After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group. Receives: Procedure: Erector spinal plane block |
| Local block group （LB group） | Placebo comparator | Local block will be performed at the surgical incisions after the surgery under general anesthesia. Receives: Procedure: Erector spinal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest(Hour 2)
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.
Measured: Hour 2
Pain intensity at rest (Hour 6)
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.
Measured: Hour 6
Pain intensity at rest (Hour 24)
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.
Measured: Hour 24
Secondary outcomes (1)
The overall dose of remifentanil
The overall dose of remifentanil used in the surgery.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single-blinded, controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648345
- Sponsor's protocol ID
- 20004-0-01
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blind，Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04648345
- Acronym / sponsor ID
- 20004-0-01
- Conditions
- Analgesia
- Keywords
- erector spinal plane block, analgesia, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 1 Dec 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.
Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）.
Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, single-blinded, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Erector spinal plane block group (ESPB group) | Experimental | Procedure: Erector spinal plane blockAfter induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. |
| Vertebral side block group (VSB group) | Active comparator | Procedure: Erector spinal plane blockAfter induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group. |
| Local block group （LB group） | Placebo comparator | Procedure: Erector spinal plane blockLocal block will be performed at the surgical incisions after the surgery under general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia
Key exclusion criteria (8 listed)
- patient refusal
- pregnancy
- history of allergy to study drugs
- neurological and cognitive disorders
- coagulopathy
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 spinal plane blockAlso: Vertebral side block, Local blockAfter induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness. | Procedure or surgery | Erector spinal plane block group (ESPB group), Local block group （LB group）, Vertebral side block group (VSB group) |
Primary outcome
Pain intensity at rest(Hour 2)
Time frame: Hour 2
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.
Pain intensity at rest (Hour 6)
Time frame: Hour 6
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.
Pain intensity at rest (Hour 24)
Time frame: Hour 24
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.
1 secondary outcome
The overall dose of remifentanil
Time frame: During the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinal plane block in people with Analgesia, run by Beijing Tsinghua Chang Gung Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siyi YAN, MD (86+010-56119610, yansiyi03@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at rest(Hour 2) (time frame: Hour 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2020.