Postoperative PainNCT04138901
Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy
A study testing Ultrasound guided subcostal transversus abdominis plane block (TAPB), Ropivacaine 0.75% Injectable Solution and 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound guided subcostal transversus abdominis plane block (TAPB), Ropivacaine 0.75% Injectable Solution and 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2019to 7 Jun 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical classification I-III
- Consent to IV-patient controlled analgesia use
- Willingness and ability to sign an informed consent document
Who cannot join
- Do not understand our study
- Allergies to anesthetic or analgesic medications
- Wound infiltration analgesia for postoperative pain control
- Infection or anatomic abnormality at the needle insertion site
- Pregnancy/Breast feeder
- Medical or psychological disease that can affect the treatment response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study
This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.
Read the detailed description
Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound guided subcostal transversus abdominis plane block (TAPB), Ropivacaine 0.75% Injectable Solution, 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
- Keywords
- Postoperative pain, Stomach neoplasms, Nerve block
- Medical subject headings
- Pain, Postoperative, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided subcostal transversus abdominis plane block (TAPB)Procedure or surgery
Also called TAP block
At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.
Ropivacaine 0.75% Injectable SolutionDrug
0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)Device
0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Patients receiving bilateral subcostal TAP block. Receives: Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB); Drug: Ropivacaine 0.75% Injectable Solution; Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) |
| Group C | No intervention | Patients not receiving bilateral subcostal TAP block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl consumption during 24 hours
postoperative cumulative fentanyl consumption (mcg)
Measured: postoperative 24 hours
Secondary outcomes (4)
Total fentanyl consumption
postoperative cumulative fentanyl consumption (mcg)
Measured: postoperative 6, 12, 48 hours
Postoperative pain score
11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Measured: postoperative 6, 12, 24, 48 hours
occurrence of opioid-related side effects
Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)
Measured: postoperative 6, 12, 24, 48 hours
Rescue nonopioid(ketorolac, nefopam) analgesic requirement
Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement
Measured: postoperative 6, 12, 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start4 Nov 2019
- Primary completion30 May 2020
- Study completion7 Jun 2020
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.
- More trials run by Seoul National University 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 prospective randomized double-blinded study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, Seoul National University Hospital
- Investigators
- Hojin Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138901
- Sponsor's protocol ID
- HS-2019-01
- Status last verified
- Aug 2020
- First submitted
- 23 Oct 2019
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study
- ClinicalTrials.gov ID
- NCT04138901
- Acronym / sponsor ID
- HS-2019-01
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Stomach neoplasms, Nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 25 Oct 2019 (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.
This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.
Detailed description
Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB), Drug: Ropivacaine 0.75% Injectable Solution, Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)Patients receiving bilateral subcostal TAP block. |
| Group C | No intervention | –Patients not receiving bilateral subcostal TAP block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical classification I-III
- Consent to IV-patient controlled analgesia use
- Willingness and ability to sign an informed consent document
Key exclusion criteria (6 listed)
- Do not understand our study
- Allergies to anesthetic or analgesic medications
- Wound infiltration analgesia for postoperative pain control
- Infection or anatomic abnormality at the needle insertion site
- Pregnancy/Breast feeder
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 subcostal transversus abdominis plane block (TAPB)Also: TAP blockAt the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance. | Procedure or surgery | Group T |
| Ropivacaine 0.75% Injectable Solution0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) | Drug | Group T |
| 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) | Device | Group T |
Primary outcome
Total fentanyl consumption during 24 hours
Time frame: postoperative 24 hours
postoperative cumulative fentanyl consumption (mcg)
4 secondary outcomes
Total fentanyl consumption
Time frame: postoperative 6, 12, 48 hours
Postoperative pain score
Time frame: postoperative 6, 12, 24, 48 hours
occurrence of opioid-related side effects
Time frame: postoperative 6, 12, 24, 48 hours
Rescue nonopioid(ketorolac, nefopam) analgesic requirement
Time frame: postoperative 6, 12, 24, 48 hours
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 13 Aug 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.
Hojin Lee, MD principal investigator
Seoul National University Hospital
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 subcostal transversus abdominis plane block (TAPB), Ropivacaine 0.75% Injectable Solution and 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) in people with Postoperative Pain, run by Seoul National University Hospital 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 6 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 13 Aug 2020. 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?
Total fentanyl consumption during 24 hours (time frame: postoperative 24 hours). 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 Aug 2020.