Abdominal CancerNCT06384677
Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery
A study testing M-Tapa Block in people with Abdominal Cancer and Abdomen Disease, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Cancer, Abdomen Disease
- What is being tested?
- M-Tapa Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 1 Feb 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient > 17 years old
- ASA score 1-3
- undergoing major intra-abdominal surgery
Who cannot join
- ASA IV patients
- patients with known neurological or psychiatric disorders
- patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
- patients with long-term drug (opioid) or alcohol dependence
- patients with BMI>30
- patients with intellectual disability
- patients who developed massive bleeding and coagulopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Research and Training Hospital
Istanbul
About this study
This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.
Read the detailed description
The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.
- Conditions
- Abdominal Cancer, Abdomen Disease
- Being tested
- M-Tapa Block
- Keywords
- major abdominal surgery, M-TAPA, opioid consumption, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-Tapa BlockOther
M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| M-Tapa + IV PCA applied group | Other | After appropriate skin disinfection, the transversus abdominis, internal oblique and external oblique muscles were determined with a high-frequency linear probe (Esaote) at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal border. A 21-G, 80-mm peripheral block needle was placed in the cranial direction using the in-plane technique, the needle tip did not exceed the cranial edge of the 10th costal cartilage, and 20 ml of 0.25% bupivacaine was applied to the lower surface of the chondrium on both sides, right and left. . Receives: Other: M-Tapa Block |
| IV PCA applied group | Other | In the IV PCA group, the surgeon performed local infiltration with 40 mL of 0.25% bupivacaine around the incisions. All patients were provided postoperative analgesia with intravenous patient-controlled analgesia (IVHKA). When pain was expressed by the patient, the patient pressed a button and the IV HKA pump was programmed to deliver a 1 ml bolus dose with a 10-minute lockout interval and no background infusion allowed. Each 1 ml of IVHKA solution contains 1 mg of morphine. Receives: Other: M-Tapa Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
The postoperative opioid consumption
Measured: Postoperative 24 hours
Secondary outcomes (3)
NRS Scores
Numeric Rating Scale score (rating from 1 to 10. 1:no pain to 10: worst pain ever)
Measured: postoperative 24 hours
the need for rescue analgesia
if NRS>4: apply rescue analgesia: the total count of rescue analgesia need
Measured: postoperative 24 hours
side effects
nausea- vomiting
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 posted25 Apr 2024
- Study start20 Apr 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GAMZE ÇABAKLI, Study chair, Marmara Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384677
- Sponsor's protocol ID
- 03.03.2023/371
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoyme U, Baumueller A, Madsen PO. Antibiotics excretion in canine vaginal and urethral secretions. Invest Urol. 1978 Jul;16(1):35-8.
PubMed 29017
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery
- ClinicalTrials.gov ID
- NCT06384677
- Acronym / sponsor ID
- 03.03.2023/371
- Conditions
- Abdominal Cancer, Abdomen Disease
- Keywords
- major abdominal surgery, M-TAPA, opioid consumption, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 25 Apr 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.
This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.
Detailed description
The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-Tapa + IV PCA applied group | Other | Other: M-Tapa BlockAfter appropriate skin disinfection, the transversus abdominis, internal oblique and external oblique muscles were determined with a high-frequency linear probe (Esaote) at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal border. A 21-G, 80-mm peripheral block needle was placed in the cranial direction using the in-plane technique, the needle tip did not exceed the cranial edge of the 10th costal cartilage, and 20 ml of 0.25% bupivacaine was applied to the lower surface of the chondrium on both sides, right and left. . |
| IV PCA applied group | Other | Other: M-Tapa BlockIn the IV PCA group, the surgeon performed local infiltration with 40 mL of 0.25% bupivacaine around the incisions. All patients were provided postoperative analgesia with intravenous patient-controlled analgesia (IVHKA). When pain was expressed by the patient, the patient pressed a button and the IV HKA pump was programmed to deliver a 1 ml bolus dose with a 10-minute lockout interval and no background infusion allowed. Each 1 ml of IVHKA solution contains 1 mg of morphine. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient > 17 years old
- ASA score 1-3
- undergoing major intra-abdominal surgery
Key exclusion criteria (7 listed)
- ASA IV patients
- patients with known neurological or psychiatric disorders
- patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
- patients with long-term drug (opioid) or alcohol dependence
- patients with BMI>30
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 was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery | Other | IV PCA applied group, M-Tapa + IV PCA applied group |
Primary outcome
Opioid Consumption
Time frame: Postoperative 24 hours
The postoperative opioid consumption
3 secondary outcomes
NRS Scores
Time frame: postoperative 24 hours
the need for rescue analgesia
Time frame: postoperative 24 hours
side effects
Time frame: postoperative 24 hours
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 Aug 2024.
- Background: PubMed 29017Hoyme U, Baumueller A, Madsen PO. Antibiotics excretion in canine vaginal and urethral secretions. Invest Urol. 1978 Jul;16(1):35-8.
- 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.
GAMZE ÇABAKLI study chair
Marmara Univercity
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 in people with Abdominal Cancer and Abdomen Disease, run by Marmara University 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 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 26 Aug 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?
Opioid Consumption (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?
On the ClinicalTrials.gov record for NCT06384677, which also lists 1 linked publication.
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 Aug 2024.