Postoperative PainNCT04238780
Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation
A study testing Erector Spinae Plane Block in people with Postoperative Pain, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block
- 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 siteSouth Korea
- Study dates
- 20 Feb 2020to 20 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 and 70 years, with an American Society of Anesthesiologists physical status of 1 or 2, who were scheduled for laparoscopic colorectal operation
Who cannot join
- sensitivity to local anesthetic, bleeding disorders , receiving anticoagulant, body mass index (BMI) over 35/kg/m2 spine or chest wall deformity pregnancy tolerance to opioid analgesics inability to use patient-controlled analgesia (PCA)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University College of Medicine, Gil Hospital
Incheon, 21565
jungju choi, MD,PHD, 82324603637, jjchoi2@gilhospital.com
hyung jeong kwak, MD,PHD, 82324603637
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation: A Randomized Controlled Study
The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.
Read the detailed description
.The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Intravenous fentanyl patient control device
- 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 Spinae Plane BlockProcedure or surgery
The transducer was placed vertically 3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine needle was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml local anesthetics is done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back.
Intravenous fentanyl patient control deviceProcedure or surgery
24-hour fentanyl consumption will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| ESP( Erector Spinae Plane Block) | Active comparator | After induction parturient in the ESPB underwent bilateral ESPB at the level of T7 using a linear ultrasound (US) transducer.
Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded. Receives: Procedure: Erector Spinae Plane Block; Procedure: Intravenous fentanyl patient control device |
| control group | Active comparator | No regional anesthesia technique will be applied to the control group.
Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded. Receives: Procedure: Intravenous fentanyl patient control device |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale on rest and cough
In the recovery room, post op 6hours, post op 24 hours
Measured: 24 hours after surgery
Secondary outcomes (3)
opioid consumption
In the recovery room, post op 6hours, post op 24 hours
Measured: 24 hours after surgery
Quality of Recovery
pre operative QoR 40 scores compares
Measured: 1day before operation, post op 24 hours
need for analgesics
Number of patients who required analgesic in the first 24 hour
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start20 Feb 2020
- Primary completion20 Jun 2023
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Ju Choi, Gachon University Gil Medical Center
- Investigators
- hyunjeong kwack, md,phd, Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238780
- Sponsor's protocol ID
- ESPlapaAR
- Status last verified
- Sep 2023
- First submitted
- 20 Jan 2020
- Last updated
- 13 Sep 2023
- Results posted
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04238780
- Acronym / sponsor ID
- ESPlapaAR
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 23 Jan 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.
The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.
Detailed description
.The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP( Erector Spinae Plane Block) | Active comparator | Procedure: Erector Spinae Plane Block, Procedure: Intravenous fentanyl patient control deviceAfter induction parturient in the ESPB underwent bilateral ESPB at the level of T7 using a linear ultrasound (US) transducer. Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded. |
| control group | Active comparator | Procedure: Intravenous fentanyl patient control deviceNo regional anesthesia technique will be applied to the control group. Intravenous fentanyl patient control device 24-hour fentanyl consumption will be recorded. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 20 and 70 years, with an American Society of Anesthesiologists physical status of 1 or 2, who were scheduled for laparoscopic colorectal operation
Key exclusion criteria (1 listed)
- sensitivity to local anesthetic, bleeding disorders , receiving anticoagulant, body mass index (BMI) over 35/kg/m2 spine or chest wall deformity pregnancy tolerance to opioid analgesics inability to use patient-controlled analgesia (PCA)
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 Spinae Plane BlockThe transducer was placed vertically 3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine needle was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml local anesthetics is done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back. | Procedure or surgery | ESP( Erector Spinae Plane Block) |
| Intravenous fentanyl patient control device24-hour fentanyl consumption will be recorded. | Procedure or surgery | ESP( Erector Spinae Plane Block), control group |
Primary outcome
numerical rating scale on rest and cough
Time frame: 24 hours after surgery
In the recovery room, post op 6hours, post op 24 hours
3 secondary outcomes
opioid consumption
Time frame: 24 hours after surgery
Quality of Recovery
Time frame: 1day before operation, post op 24 hours
need for analgesics
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
hyunjeong kwack, md,phd study director
Gachon University Gil 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 Erector Spinae Plane Block in people with Postoperative Pain, run by Gachon University Gil 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 1 inclusion and 1 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 13 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jungju choi, nd,phd (8232 460 3624, jjchoi2@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale on rest and cough (time frame: 24 hours after surgery). 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 13 Sep 2023.