Regional Anesthesia MorbidityNCT06482229
M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin
A study testing application for postoperative analgesia in people with Regional Anesthesia Morbidity, run by Sivas State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- application for postoperative analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy surgery planned
- ASA #-II-III classification
- Willingness to participate in the study
Who cannot join
- Bleeding disorders
- Signs of infection at the block application site
- Conversion to open surgery
- Allergy to local anesthetics
- Unstable hemodynamics
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Efficacy of Intraperitoneal Bupivacaine, Bupivacaine and Dexmedetomidine With Modified-Pericondrial Approach Thoracoabdominal Nerve Block (M-TAPA) in Laparoscopic Cholecystectomy Surgeries
Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- application for postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application for postoperative analgesiaProcedure or surgery
three different methods will be applied to reduce patients' postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| m-tapa | Experimental | Not described Receives: Procedure: application for postoperative analgesia |
| intraperitoneal bupivacain | Experimental | Not described Receives: Procedure: application for postoperative analgesia |
| intraperitoneal bupivacain+dexmedetomidin | Experimental | Not described Receives: Procedure: application for postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
zero meaning "no pain" and 10 meaning "the worst pain imaginable
Measured: Time Frame: 24 hours after the procedure
Secondary outcomes (1)
total analgesic consumption
total rescue analgesic consumption of patients will be evaluated
Measured: 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sivas State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Balcı, Sivas State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482229
- Sponsor's protocol ID
- m-tapa vs intraperiton
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Intraperitoneal Bupivacaine, Bupivacaine and Dexmedetomidine With Modified-Pericondrial Approach Thoracoabdominal Nerve Block (M-TAPA) in Laparoscopic Cholecystectomy Surgeries
- ClinicalTrials.gov ID
- NCT06482229
- Acronym / sponsor ID
- m-tapa vs intraperiton
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sivas State HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 1 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.
Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| m-tapa | Experimental | Procedure: application for postoperative analgesia |
| intraperitoneal bupivacain | Experimental | Procedure: application for postoperative analgesia |
| intraperitoneal bupivacain+dexmedetomidin | Experimental | Procedure: application for postoperative analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laparoscopic cholecystectomy surgery planned
- ASA #-II-III classification
- Willingness to participate in the study
Key exclusion criteria (6 listed)
- Bleeding disorders
- Signs of infection at the block application site
- Conversion to open surgery
- Allergy to local anesthetics
- Unstable hemodynamics
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 |
|---|---|---|
| application for postoperative analgesiathree different methods will be applied to reduce patients' postoperative pain | Procedure or surgery | intraperitoneal bupivacain, intraperitoneal bupivacain+dexmedetomidin, m-tapa |
Primary outcome
pain scores
Time frame: Time Frame: 24 hours after the procedure
zero meaning "no pain" and 10 meaning "the worst pain imaginable
1 secondary outcome
total analgesic consumption
Time frame: 24 hours after the procedure
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 26 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application for postoperative analgesia in people with Regional Anesthesia Morbidity, run by Sivas State 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: finished, as of the sponsor's last update on 26 Oct 2024. 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?
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?
pain scores (time frame: Time Frame: 24 hours after the procedure). 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 26 Oct 2024.