Visceral Pain, PostoperativeNCT03767816
The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
A study testing Ultrasound guided Rectus sheath block and Ultrasound erector spinae plane block in people with Visceral Pain, Postoperative, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Visceral Pain, Postoperative
- What is being tested?
- Ultrasound guided Rectus sheath block and Ultrasound erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2018to 30 Jun 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults between the ages of 20 and 80
- scheduled laparoscopic cholecystectomy patient
- American society of anesthesiologists score 1 or 2
- Patients who have voluntarily agreed in writing to participate in the trial
Who cannot join
- Patient with side effects on local anesthetics or steroids
- Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
- Patients with uncontrolled medical or psychiatric problem
- Patient does not agree to participate in the study
- Patients with deformity at vertebra or chest wall.
- Patients who are pregnant or lactating
- Patients receiving a single laparoscopic cholecystectomy (including using a robot)
- Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.
After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.
NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected
- Conditions
- Visceral Pain, Postoperative
- Being tested
- Ultrasound guided Rectus sheath block, Ultrasound erector spinae plane block
- Keywords
- laparoscopic cholecystectomy, erector spinae plane block, visceral pain
- Medical subject headings
- Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Rectus sheath blockDrug
Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus
Ultrasound erector spinae plane blockDrug
Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level
| Study group | Role | What they receive |
|---|---|---|
| Group R : Rectus sheath block group | Experimental | ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision Receives: Drug: Ultrasound guided Rectus sheath block |
| Group RE: Rectus sheath block and erector spinae plane block | Active comparator | ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml Receives: Drug: Ultrasound guided Rectus sheath block; Drug: Ultrasound erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of analgesic consumption between both group
The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5,
1, 2, 6, 12, 18, 24 hours after operation) to compare.
Measured: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation
Secondary outcomes (1)
compare the Numeric rating scale (NRS)
10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.
After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).
Measured: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start17 Dec 2018
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hyuk Lee, Asan Medical Center
- Investigators
- JongHyuk Lee, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767816
- Sponsor's protocol ID
- 2018-1320
- Status last verified
- Jul 2019
- First submitted
- 15 Nov 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03767816
- Acronym / sponsor ID
- 2018-1320
- Conditions
- Visceral Pain, Postoperative
- Keywords
- laparoscopic cholecystectomy, erector spinae plane block, visceral pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Dec 2018 (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.
The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.
After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.
NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R : Rectus sheath block group | Experimental | Drug: Ultrasound guided Rectus sheath blockultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision |
| Group RE: Rectus sheath block and erector spinae plane block | Active comparator | Drug: Ultrasound guided Rectus sheath block, Drug: Ultrasound erector spinae plane blockultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults between the ages of 20 and 80
- scheduled laparoscopic cholecystectomy patient
- American society of anesthesiologists score 1 or 2
- Patients who have voluntarily agreed in writing to participate in the trial
Key exclusion criteria (8 listed)
- Patient with side effects on local anesthetics or steroids
- Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
- Patients with uncontrolled medical or psychiatric problem
- Patient does not agree to participate in the study
- Patients with deformity at vertebra or chest wall.
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 |
|---|---|---|
| Ultrasound guided Rectus sheath blockUltrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus | Drug | Group R : Rectus sheath block group, Group RE: Rectus sheath block and erector spinae plane block |
| Ultrasound erector spinae plane blockUltrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level | Drug | Group RE: Rectus sheath block and erector spinae plane block |
Primary outcome
Difference of analgesic consumption between both group
Time frame: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation
The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation) to compare.
1 secondary outcome
compare the Numeric rating scale (NRS)
Time frame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
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 5 Jul 2019.
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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.
JongHyuk Lee, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Rectus sheath block and Ultrasound erector spinae plane block in people with Visceral Pain, Postoperative, run by Asan Medical Center at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 5 Jul 2019. 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 South Korea. 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?
Difference of analgesic consumption between both group (time frame: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation). 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 5 Jul 2019.