Postoperative Pain, AcuteNCT05207306
Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy
A study testing Type of interfascial plane block in people with Postoperative Pain, Acute, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Type of interfascial plane block
- Type of treatment
- 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
- 5 Apr 2022to 12 Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical classification I-II
Who cannot join
- American Society of Anesthesiologists (ASA) physical classification III or more
- Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- Allergies to anesthetic or analgesic medications used in the protocol
- Single port laparoscopic cholecystectomy
- Patients with infection at the abdominal wall
- Medical or psychological disease that can affect the treatment response
- Do not understand our study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Please Select An Option, 03080
About this study
Official title: Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study
This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).
Read the detailed description
Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Type of interfascial plane block
- Keywords
- cholecystectomy, thoracoabdominal nerves block, transversus abdominis plane block, interfascial plane block, regional analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of interfascial plane blockProcedure or surgery
In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way.
In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.
| Study group | Role | What they receive |
|---|---|---|
| Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group | Experimental | Patients receiving right M-TAPA. Receives: Procedure: Type of interfascial plane block |
| Subcostal transversus abdominis plane block (subcostal TAPB) group | Experimental | Patients receiving right subcostal TAPB. Receives: Procedure: Type of interfascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum postoperative pain score during 12hours postoperatively
maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively
Measured: at 12hour postoperatively.
Secondary outcomes (4)
Postoperative pain score at rest
Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting
Measured: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Postoperative pain score during coughing
Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing
Measured: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Patient satisfaction before discharge
Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction)
Measured: at immediately before discharge
Occurrence rate of postoperative nausea, vomiting
Incidence of postoperative nausea and vomiting (%)
Measured: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start5 Apr 2022
- Primary completion12 Feb 2023
- Study completion12 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies 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 controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207306
- Sponsor's protocol ID
- 2111-040-1270
- Status last verified
- Aug 2023
- First submitted
- 2 Jan 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
PubMed 31212124Ueshima H, Hiroshi O. RETRACTED: Thoracoabdominal nerves block through the perichondral approach for effective perioperative analgesia during upper abdominal surgery. J Clin Anesth. 2020 Feb;59:7. doi: 10.1016/j.jclinane.2019.06.008. Epub 2019 Jun 5. No abstract available.
PubMed 31176261Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.
PubMed 22967210Oksar M, Koyuncu O, Turhanoglu S, Temiz M, Oran MC. Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. J Clin Anesth. 2016 Nov;34:72-8. doi: 10.1016/j.jclinane.2016.03.033. Epub 2016 May 2.
PubMed 27687350Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
PubMed 30396100
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05207306
- Acronym / sponsor ID
- 2111-040-1270
- Conditions
- Postoperative Pain, Acute
- Keywords
- cholecystectomy, thoracoabdominal nerves block, transversus abdominis plane block, interfascial plane block, regional analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 26 Jan 2022 (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 randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).
Detailed description
Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.
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 controlled trial
| Arm | Type | Receives |
|---|---|---|
| Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group | Experimental | Procedure: Type of interfascial plane blockPatients receiving right M-TAPA. |
| Subcostal transversus abdominis plane block (subcostal TAPB) group | Experimental | Procedure: Type of interfascial plane blockPatients receiving right subcostal TAPB. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical classification I-II
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists (ASA) physical classification III or more
- Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- Allergies to anesthetic or analgesic medications used in the protocol
- Single port laparoscopic cholecystectomy
- Patients with infection at the abdominal 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 |
|---|---|---|
| Type of interfascial plane blockIn the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way. In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way. | Procedure or surgery | Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group, Subcostal transversus abdominis plane block (subcostal TAPB) group |
Primary outcome
Maximum postoperative pain score during 12hours postoperatively
Time frame: at 12hour postoperatively.
maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively
4 secondary outcomes
Postoperative pain score at rest
Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Postoperative pain score during coughing
Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Patient satisfaction before discharge
Time frame: at immediately before discharge
Occurrence rate of postoperative nausea, vomiting
Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.
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 22 Aug 2023.
- Background: PubMed 31212124Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
- Background: PubMed 31176261Ueshima H, Hiroshi O. RETRACTED: Thoracoabdominal nerves block through the perichondral approach for effective perioperative analgesia during upper abdominal surgery. J Clin Anesth. 2020 Feb;59:7. doi: 10.1016/j.jclinane.2019.06.008. Epub 2019 Jun 5. No abstract available.
- Background: PubMed 22967210Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.
- Background: PubMed 27687350Oksar M, Koyuncu O, Turhanoglu S, Temiz M, Oran MC. Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. J Clin Anesth. 2016 Nov;34:72-8. doi: 10.1016/j.jclinane.2016.03.033. Epub 2016 May 2.
- Background: PubMed 30396100Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
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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 study chair
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 Type of interfascial plane block in people with Postoperative Pain, Acute, 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 2 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 22 Aug 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?
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?
Maximum postoperative pain score during 12hours postoperatively (time frame: at 12hour postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207306, which also lists 5 linked publications.
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 22 Aug 2023.