Preemptive Peripheral Nerve BlockNCT03413280
Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients
A study testing Ultrasound guided Rectus sheath block and Intercostal nerve block in people with Preemptive Peripheral Nerve Block and 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 preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC). After induction of general anesthesia, group of patient is decided randomly. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Preemptive Peripheral Nerve Block, Pain, Postoperative, Acute Pain
- What is being tested?
- Ultrasound guided Rectus sheath block and Intercostal nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2017to 15 Jan 2018
- 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
- ASA class 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 who are pregnant or lactating
- Patients whose visceral pain is expected to be too severe
- Patients receiving a single laparoscopic cholecystectomy (including using a robot)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy
The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).
After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.
Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.
- Being tested
- Ultrasound guided Rectus sheath block, Intercostal nerve block
- Keywords
- preemptive analgic effect, Rectus Sheath Block, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative, Acute 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 0.25% ropivacaine 34ml around umbilicus
Intercostal nerve blockDrug
Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space
| Study group | Role | What they receive |
|---|---|---|
| preoperative Rectus sheath block: group Pre | Experimental | ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision Receives: Drug: Ultrasound guided Rectus sheath block; Drug: Intercostal nerve block |
| postoperative Rectus sheath block: group Post | Active comparator | ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision Receives: Drug: Ultrasound guided Rectus sheath block; Drug: Intercostal nerve 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, 9, 18, 24 hours after operation) to compare.
Measured: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Secondary outcomes (1)
compare the Numeric rating scale (NRS)
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 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, 9, 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 posted29 Jan 2018
- Study start28 Mar 2017
- Primary completion25 Aug 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preemptive Peripheral Nerve BlockStudies 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
- 200 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
- NCT03413280
- Sponsor's protocol ID
- 2017-0301
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2018
- Last updated
- 23 Jan 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03413280
- Acronym / sponsor ID
- 2017-0301
- Keywords
- preemptive analgic effect, Rectus Sheath Block, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 29 Jan 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 preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).
After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.
Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.
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 |
|---|---|---|
| preoperative Rectus sheath block: group Pre | Experimental | Drug: Ultrasound guided Rectus sheath block, Drug: Intercostal nerve blockultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision |
| postoperative Rectus sheath block: group Post | Active comparator | Drug: Ultrasound guided Rectus sheath block, Drug: Intercostal nerve blockultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision |
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
- ASA class 1 or 2
- Patients who have voluntarily agreed in writing to participate in the trial
Key exclusion criteria (7 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 who are pregnant or lactating
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 0.25% ropivacaine 34ml around umbilicus | Drug | postoperative Rectus sheath block: group Post, preoperative Rectus sheath block: group Pre |
| Intercostal nerve blockUltrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space | Drug | postoperative Rectus sheath block: group Post, preoperative Rectus sheath block: group Pre |
Primary outcome
Difference of analgesic consumption between both group
Time frame: at 0, 0.5, 1, 2, 6, 9, 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, 9, 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 23 Jan 2019.
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 Intercostal nerve block in people with Preemptive Peripheral Nerve Block and 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 7 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 23 Jan 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, 9, 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 23 Jan 2019.