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
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.
- 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