Laparoscopic CholecystectomyM-TAPANCT05017090
Analgesic Effect of Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach
A study testing M-TAPA block and Standard perioperative and postoperative multimodal analgesia in people with Laparoscopic Cholecystectomy, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- M-TAPA block and Standard perioperative and postoperative multimodal analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2021to 10 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study
Who cannot join
- presence of coagulation disorder
- refuse to participate
- infection at the injection site of the block
- known allergy to local anesthetics
- advanced hepatic or renal failure
- can not communicate in Turkish
Show all 13Show fewer
- history of abdominal surgery or trauma
- conversion of laparoscopic to open surgery
- consumption of any pain killers within the 24 h before the operation
- chronic opioid consumption
- pregnancy
- alcohol or drug abuse
- body mass index (BMI) ≥ 35 kg m-2.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach in Patients Undergoing Laparoscopic Cholecystectomy
This study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this block are lacking. In this prospective interventional trial, the investigators aim to define the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general anesthesia.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, the patients in the Group M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- M-TAPA block, Standard perioperative and postoperative multimodal analgesia
- Keywords
- Modified-thoracoabdominal nerves block, Acute pain, laparoscopic cholecystectomy
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TAPA blockProcedure or surgery
Also called Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization
After tracheal intubation, a high-frequency linear probe will placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.
Standard perioperative and postoperative multimodal analgesiaOther
Also called Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization
The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.
| Study group | Role | What they receive |
|---|---|---|
| Group N | Sham comparator | The patients in Group N will not receive any intervention. In the intervention and control groups, block sites will be covered with dressings, and patients and other health care workers will be blinded to treatment allocation. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. Receives: Other: Standard perioperative and postoperative multimodal analgesia |
| Group M-TAPA | Experimental | After tracheal intubation, a high-frequency linear probe will be placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will be inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. Receives: Procedure: M-TAPA block; Other: Standard perioperative and postoperative multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale scores
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
Measured: 24 hours
Secondary outcomes (5)
Opioid consumption
If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.
Measured: 24 hours
Adverse events
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Measured: 24 hours
Metoclopromide consumption
The severity of the nausea will be assessed on a 4 -point scale (0=none 1=mild, 2=moderate 3=severe). If the patients nausea score is ≥2 the patient will receive 10 mg metoclopromide.
Measured: 24 hours
Sedation score
Sedation level of the patients will be assessed on a 4-point scale (0=alert, 1=sleepy, easy to arouse verbally, 2= drowsy, 3=does not open eyes to verbal commands) at postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour.
Measured: 24 hours
Quality of recovery levels between groups by using QoR-40 questionnaire
QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.Global QoR-40 scores range from 40 to 200 representing, respectively, very poor to outstanding quality of recovery. QoR-40 score will be recorded on the morning of operation and at the postoperative 24th hour.
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start24 Aug 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Basaran, MD, DESA, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017090
- Sponsor's protocol ID
- 05-2021/09
- Acronym
- M-TAPA
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05017090
- Acronym / sponsor ID
- M-TAPA / 05-2021/09
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Modified-thoracoabdominal nerves block, Acute pain, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 23 Aug 2021 (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 study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this block are lacking. In this prospective interventional trial, the investigators aim to define the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general anesthesia.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, the patients in the Group M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group N | Sham comparator | Other: Standard perioperative and postoperative multimodal analgesiaThe patients in Group N will not receive any intervention. In the intervention and control groups, block sites will be covered with dressings, and patients and other health care workers will be blinded to treatment allocation. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. |
| Group M-TAPA | Experimental | Procedure: M-TAPA block, Other: Standard perioperative and postoperative multimodal analgesiaAfter tracheal intubation, a high-frequency linear probe will be placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will be inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study
Key exclusion criteria (13 listed)
- presence of coagulation disorder
- refuse to participate
- infection at the injection site of the block
- known allergy to local anesthetics
- advanced hepatic or renal failure
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 blockAlso: Global Quality of Recovery-40 score, Standard Pain Followup and MonitorizationAfter tracheal intubation, a high-frequency linear probe will placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side. | Procedure or surgery | Group M-TAPA |
| Standard perioperative and postoperative multimodal analgesiaAlso: Global Quality of Recovery-40 score, Standard Pain Followup and MonitorizationThe pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. | Other | Group M-TAPA, Group N |
Primary outcome
Numerical Rating Scale scores
Time frame: 24 hours
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
5 secondary outcomes
Opioid consumption
Time frame: 24 hours
Adverse events
Time frame: 24 hours
Metoclopromide consumption
Time frame: 24 hours
Sedation score
Time frame: 24 hours
Quality of recovery levels between groups by using QoR-40 questionnaire
Time frame: Postoperative 24th hour
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 Dec 2021.
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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.
Betul Basaran, MD, DESA study director
Karaman Training and Research 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 M-TAPA block and Standard perioperative and postoperative multimodal analgesia in people with Laparoscopic Cholecystectomy, run by Karaman 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 1 inclusion and 13 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 Dec 2021. 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. Some participants in this study may receive a placebo. 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?
Numerical Rating Scale scores (time frame: 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 Dec 2021.