Post Operative PainNCT06483581
Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Appendectomy Surgeries
A study testing M-TAPA block with bupivacaine 25% and TAP block with bupivacaine 25% in people with Post Operative Pain, run by Cumhuriyet University.
Trial summary
The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- M-TAPA block with bupivacaine 25% and TAP block with bupivacaine 25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Sep 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients older than 18 years of age who will undergo laparoscopic appendectomy under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Who cannot join
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients undergoing open surgery,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Appendectomy Surgeries
The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries
Read the detailed description
There will be two randomized groups: Group M-TAPA (n=15), Group TAP (n=15). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed after general anesthesia induction, before skin incision. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.
- Conditions
- Post Operative Pain
- Being tested
- M-TAPA block with bupivacaine 25%, TAP block with bupivacaine 25%
- Keywords
- m-tapa, tap block, laparoscopic appendectomy, regional anesthesia, postoperative pain
- 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 block with bupivacaine 25%Other
Also called Modified thoracoabdominal nerve block through perichondrial approach
Following sterile conditions for bilateral M-TAPA block application, the transducer will be inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle will be created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip will be placed just below the chondrium and saline (5 ml) will be injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine will be administered for each group for a total of 40 ml of local anesthetic. Blocks will be applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose will be applied to the contralateral side for each group of M-TAPA patients.
TAP block with bupivacaine 25%Other
Also called Transversus abdominis plane block
After the necessary sterilization conditions established, the linear ultrasound probe will be placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum will be identified. As the tip of the 80 mm sonovisible needle passes through the muscular layers and fascia, the needle will be advanced in a controlled manner. After receiving the click sensation (passage of the fascia of the internal oblique muscle), the location of the needle will be fixed and 20 ml of 0.25% bupivacaine will be injected between internal oblique and transversus abdominis muscles. Same procedure will be performed to the other site. (40 ml local anesthetics in total)
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA | Active comparator | Patients will have bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) before the surgery for postoperative pain control. Receives: Other: M-TAPA block with bupivacaine 25% |
| TAP | Active comparator | Patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml) before the surgery for postoperative pain control. Receives: Other: TAP block with bupivacaine 25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the numerical rating scale scores
Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Comparing total tramadol consumption
Postoperative analgesic need
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483581
- Sponsor's protocol ID
- M-TAPA vs TAP in appendectomy
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Appendectomy Surgeries
- ClinicalTrials.gov ID
- NCT06483581
- Acronym / sponsor ID
- M-TAPA vs TAP in appendectomy
- Conditions
- Post Operative Pain
- Keywords
- m-tapa, tap block, laparoscopic appendectomy, regional anesthesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Jul 2024 (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 compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries
Detailed description
There will be two randomized groups: Group M-TAPA (n=15), Group TAP (n=15). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed after general anesthesia induction, before skin incision. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TAPA | Active comparator | Other: M-TAPA block with bupivacaine 25%Patients will have bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) before the surgery for postoperative pain control. |
| TAP | Active comparator | Other: TAP block with bupivacaine 25%Patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml) before the surgery for postoperative pain control. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients older than 18 years of age who will undergo laparoscopic appendectomy under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Key exclusion criteria (8 listed)
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
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 block with bupivacaine 25%Also: Modified thoracoabdominal nerve block through perichondrial approachFollowing sterile conditions for bilateral M-TAPA block application, the transducer will be inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle will be created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip will be placed just below the chondrium and saline (5 ml) will be injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine will be administered for each group for a total of 40 ml of local anesthetic. Blocks will be applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose will be applied to the contralateral side for each group of M-TAPA patients. | Other | M-TAPA |
| TAP block with bupivacaine 25%Also: Transversus abdominis plane blockAfter the necessary sterilization conditions established, the linear ultrasound probe will be placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum will be identified. As the tip of the 80 mm sonovisible needle passes through the muscular layers and fascia, the needle will be advanced in a controlled manner. After receiving the click sensation (passage of the fascia of the internal oblique muscle), the location of the needle will be fixed and 20 ml of 0.25% bupivacaine will be injected between internal oblique and transversus abdominis muscles. Same procedure will be performed to the other site. (40 ml local anesthetics in total) | Other | TAP |
Primary outcome
Comparing the numerical rating scale scores
Time frame: Postoperative 24 hours
Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
1 secondary outcome
Comparing total tramadol consumption
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Oğuz Gündoğdu principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A study testing M-TAPA block with bupivacaine 25% and TAP block with bupivacaine 25% in people with Post Operative Pain, run by Cumhuriyet University.
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 8 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Oğuz Gündoğdu (+905545945469, droguzgundogdu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the numerical rating scale scores (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 3 Jul 2024.