Post Operative PainM-TAPANCT06039150
Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies
A study testing M-TAPA Block and Local anesthetic infltration to port sites in people with Post Operative Pain and Laparoscopic Surgery, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are: Is M-TAPA block more effective in reducing pain? How M-TAPA block affects the use of rescue analgesics in the postoperative period?… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Post Operative Pain, Laparoscopic Surgery, Pediatrics
- What is being tested?
- M-TAPA Block and Local anesthetic infltration to port sites
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2023to 21 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with American society of Anesthesiologists (ASA) physical status I-II,
- Patients which will undergo Laparoscopic appendectomy due to the diagnosis of acute appendicitis,
- Patients whose parents or legal heirs have consented to participate in the study
Who cannot join
- Patients with Society of Anesthesiologists (ASA) III-IV status,
- Patients whose parents or legal heirs' disapproval,
- Patients inability to cooperate,
- Patients who have allergy to any of the medications used in the study,
- Patients with perforated appendix
- When the Laparoscopic surgery returns to open shape
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Kecioren, 06010
About this study
Official title: Medical Doctor of Anesthesiology and Reanimation
To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are:
- Is M-TAPA block more effective in reducing pain?
- How M-TAPA block affects the use of rescue analgesics in the postoperative period? Participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. Participants in the M-TAPA group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.
- Conditions
- Post Operative Pain, Laparoscopic Surgery, Pediatrics, Regional Anesthesia, Local Anesthetic
- Being tested
- M-TAPA Block, Local anesthetic infltration to port sites
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TAPA BlockProcedure or surgery
M-TAPA Block; The block will be done by the same experienced anesthesiologist by using ultrasound(USG) after the surgical intervention is completed.The external oblique, internal oblique, and transversus abdominis muscles were shown on the costochondral angle in the sagittal plane at the 10th costal margin by using a high-frequency linear probe. Bilaterally in the midclavicular line at the level of the 10th rib (arcus costarum),0,5 ml/kg 0.25% Bupivacaine (maximum dose 2mg/kg) was administered to between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue.
Local anesthetic infltration to port sitesProcedure or surgery
Local anesthetic infiltration to port sites; The surgeon infiltrated 0.5 ml/kg of 0.25% Bupivacaine (maximum dose of 2mg/kg) in the skin, subcutaneous tissue, and muscle fascia at each of the three laparoscopic port areas at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA group | Experimental | The group to be administered 0.025% Bupivacaine by the anesthesiologist bilaterally in M-TAPA block with a maximum dose of 2 mg/kg before extubation. Receives: Procedure: M-TAPA Block |
| LAİ group | Active comparator | The group to be divided and administered 0.025% Bupivacaine with a maximum dose of 2 mg/kg by the surgeon to 3 port entry sites before extubation Receives: Procedure: Local anesthetic infltration to port sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of rescue analgesic applications
During the first 24 hours postoperatively, patients' pain will be monitored by Visual Analogue Scale (VAS) scoring. Paracetamol will be given intravenously at a dose of 10mg/kg if the VAS is greater than 4 in pain assessment in the postoperative period. We will record the number of times the patient received rescue analgesics over a 24-hour period.
Measured: Postoperative first 24 hours
Secondary outcomes (1)
Comparison of pain between 2 groups in the postoperative period
The Visual Analogue Scale (VAS) scores were recorded postoperatively at 0 (PACU), 1, 4, 6, 12, and 24 h.
Visual Analogue Scale (VAS)
Scale vertical or horizontal from a 10 cm long line drawn as is formed. At the two ends of this line are the two end descriptor word (0 = "no pain at all", 10 = worst/unbearable pain").The patient is asked to place a mark in the appropriate place for the intensity of the pain.
Measured: Postoperative first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start21 Aug 2023
- Primary completion21 Oct 2023 (estimated)
- Study completion21 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ELA ERTEN, Gulhane Training and Research Hospital
- Investigators
- ELA ERTEN, Principal investigator, Anesthesiology and Reanimation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039150
- Sponsor's protocol ID
- GULHANEELAERTEN
- Acronym
- M-TAPA
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
PubMed 21504934Ozen V, Acik ME, Ozen N. The modified thoracoabdominal nerve block for post-operative analgesia in paediatric laparoscopic cholecystectomy. J Minim Access Surg. 2024 Oct 1;20(4):452-455. doi: 10.4103/jmas.jmas_174_22. Epub 2023 May 10.
PubMed 37282431
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Doctor of Anesthesiology and Reanimation
- ClinicalTrials.gov ID
- NCT06039150
- Acronym / sponsor ID
- M-TAPA / GULHANEELAERTEN
- Conditions
- Post Operative Pain, Laparoscopic Surgery, Pediatrics, Regional Anesthesia, Local Anesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 21 Oct 2023 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 15 Sep 2023 (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.
To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are:
- Is M-TAPA block more effective in reducing pain?
- How M-TAPA block affects the use of rescue analgesics in the postoperative period? Participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. Participants in the M-TAPA group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TAPA group | Experimental | Procedure: M-TAPA BlockThe group to be administered 0.025% Bupivacaine by the anesthesiologist bilaterally in M-TAPA block with a maximum dose of 2 mg/kg before extubation. |
| LAİ group | Active comparator | Procedure: Local anesthetic infltration to port sitesThe group to be divided and administered 0.025% Bupivacaine with a maximum dose of 2 mg/kg by the surgeon to 3 port entry sites before extubation |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with American society of Anesthesiologists (ASA) physical status I-II,
- Patients which will undergo Laparoscopic appendectomy due to the diagnosis of acute appendicitis,
- Patients whose parents or legal heirs have consented to participate in the study
Key exclusion criteria (6 listed)
- Patients with Society of Anesthesiologists (ASA) III-IV status,
- Patients whose parents or legal heirs' disapproval,
- Patients inability to cooperate,
- Patients who have allergy to any of the medications used in the study,
- Patients with perforated appendix
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 |
|---|---|---|
| M-TAPA BlockM-TAPA Block; The block will be done by the same experienced anesthesiologist by using ultrasound(USG) after the surgical intervention is completed.The external oblique, internal oblique, and transversus abdominis muscles were shown on the costochondral angle in the sagittal plane at the 10th costal margin by using a high-frequency linear probe. Bilaterally in the midclavicular line at the level of the 10th rib (arcus costarum),0,5 ml/kg 0.25% Bupivacaine (maximum dose 2mg/kg) was administered to between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue. | Procedure or surgery | M-TAPA group |
| Local anesthetic infltration to port sitesLocal anesthetic infiltration to port sites; The surgeon infiltrated 0.5 ml/kg of 0.25% Bupivacaine (maximum dose of 2mg/kg) in the skin, subcutaneous tissue, and muscle fascia at each of the three laparoscopic port areas at the end of the surgery. | Procedure or surgery | LAİ group |
Primary outcome
Total number of rescue analgesic applications
Time frame: Postoperative first 24 hours
During the first 24 hours postoperatively, patients' pain will be monitored by Visual Analogue Scale (VAS) scoring. Paracetamol will be given intravenously at a dose of 10mg/kg if the VAS is greater than 4 in pain assessment in the postoperative period. We will record the number of times the patient received rescue analgesics over a 24-hour period.
1 secondary outcome
Comparison of pain between 2 groups in the postoperative period
Time frame: Postoperative first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 21504934Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
- Background: PubMed 37282431Ozen V, Acik ME, Ozen N. The modified thoracoabdominal nerve block for post-operative analgesia in paediatric laparoscopic cholecystectomy. J Minim Access Surg. 2024 Oct 1;20(4):452-455. doi: 10.4103/jmas.jmas_174_22. Epub 2023 May 10.
- 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.
ELA ERTEN principal investigator
Anesthesiology and Reanimation department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-TAPA Block and Local anesthetic infltration to port sites in people with Post Operative Pain and Laparoscopic Surgery, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 15 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 Turkey (Türkiye). 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?
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 number of rescue analgesic applications (time frame: Postoperative first 24 hours). 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 NCT06039150, which also lists 2 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 15 Sep 2023.