Transversus Abdominis Plane BlockNCT05905757
Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
A study testing Dexmedetomidin + bupivacaine and Tramadol + Bupivacaine in people with Transversus Abdominis Plane Block, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Transversus Abdominis Plane Block
- What is being tested?
- Dexmedetomidin + bupivacaine and Tramadol + Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 3 Apr 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-60 years old
- Those who will undergo elective laparoscopic cholecystectomy surgery
- Those in ASA I-II physical status
- Those who gave consent to participate in the study
Who cannot join
- Those outside the age range of 20-60
- Those outside of ASA I-II physical status
- Serious heart, lung, liver disease
- Kidney failure
- Bleeding diathesis
- Those who develop complications during the procedure
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- Those with fever, active infection
- Those who are allergic to the drugs to be used
- Those who refused to participate in the study
- Those with hypothermic and acid-base disorders
- Electrolyte disturbances such as hypokalemia, hypocalcemia
- Those taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors
- Pregnant
- Those with bleeding
- BMI 30 and above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated.
Read the detailed description
The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative evaluation was made before the operation, routine laboratory analyzes were taken, the participants were informed about the study, and their written consent was obtained. Participants were randomized into two groups.
- Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100 mg tramadol adjuvant
- Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied. After intubation, bilateral subcostal TAP block was performed by the same anesthesiologist, demographic data were recorded. Intraoperative vital signs of the participants (pulse, non-invasive blood pressure and peripheral oxygen saturation measurement), additional opioid and muscle relaxant needs, and complications were recorded. Extubation was performed after standard decurarization with atropine and neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering), postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were evaluated and recorded.
- Conditions
- Transversus Abdominis Plane Block
- Being tested
- Dexmedetomidin + bupivacaine, Tramadol + Bupivacaine
- Keywords
- Transversus abdominis plane block, adjuvant, Dexmedetomidine, Tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidin + bupivacaineProcedure or surgery
dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)
Tramadol + BupivacaineDrug
tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Group T (Adjuvant tramadol): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 40 mL adjuvant 1.5mg/kg (maximum 100 mg) tramadol.
Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), HR, SpO2 values were recorded.
Demographic data of the patients [age, weight, height, body mass index (BMI), smoking use] and operation times were recorded.
All patients were administered 1000 mg parol IV as standard analgesic before extubation.
The patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment. Receives: Drug: Tramadol + Bupivacaine |
| Group D | Experimental | Group D (adjuvant dexmedetomidine): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 0.5 mcg/kg and (maximum 50 mcg) dexmedetomidine.
All patients were administered 1000 mg parol IV as standard analgesic before extubation.
The patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.
The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. VAS 0-2: no pain, 3-4: mild pain, 5-6: moderate pain, 7-8: severe pain, 9-10: excruciating pain. Additional analgesic requirement in the postoperative period was calculated by measuring VAS>4 values. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment. Receives: Procedure: Dexmedetomidin + bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative non invasive blood pressure
non invasive blood pressure(systolic, diastolic and mean blood pressure)
Measured: 10 minutes
intraoperative opioid consumption
The necessary opioid (mcg) addiction was noted
Measured: 40 minutes
intraoperative muscle relaxant use
The necessary muscle relaxant (mg) addiction was noted
Measured: 40 minutes
intraoperative heart rate
Heart rate was noted
Measured: 5 minutes
Secondary outcomes (2)
postoperative analgesic effects
Visual analogue scale (VAS) scores were noted.pointed between 0-10. 0:No pain, 5-6-7:medium pain, 9-10:unbearable pain
Measured: 0., 3., 6. hour measurements were evaluated
Number of participants with postoperative side effects
nausea, vomiting, chills. Patients with these effects were noted. Evaluated by the number of people
Measured: 0., 3., 6. hour measurements were evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion3 Apr 2023
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 Transversus Abdominis Plane BlockStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- School of Medicine Department of Anesthesiology and Reanimation, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905757
- Sponsor's protocol ID
- 2023/2
- Status last verified
- Jun 2023
- First submitted
- 16 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Korkutata Z, Tekeli AE, Kurt N. Intraoperative and Postoperative Effects of Dexmedetomidine and Tramadol Added as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block. J Clin Med. 2023 Nov 9;12(22):7001. doi: 10.3390/jcm12227001.
PubMed 38002616
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
- ClinicalTrials.gov ID
- NCT05905757
- Acronym / sponsor ID
- 2023/2
- Conditions
- Transversus Abdominis Plane Block
- Keywords
- Transversus abdominis plane block, adjuvant, Dexmedetomidine, Tramadol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 15 Jun 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.
In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated.
Detailed description
The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative evaluation was made before the operation, routine laboratory analyzes were taken, the participants were informed about the study, and their written consent was obtained. Participants were randomized into two groups.
- Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100 mg tramadol adjuvant
- Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied. After intubation, bilateral subcostal TAP block was performed by the same anesthesiologist, demographic data were recorded. Intraoperative vital signs of the participants (pulse, non-invasive blood pressure and peripheral oxygen saturation measurement), additional opioid and muscle relaxant needs, and complications were recorded. Extubation was performed after standard decurarization with atropine and neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering), postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were evaluated and recorded.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Drug: Tramadol + BupivacaineGroup T (Adjuvant tramadol): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 40 mL adjuvant 1.5mg/kg (maximum 100 mg) tramadol. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), HR, SpO2 values were recorded. Demographic data of the patients [age, weight, height, body mass index (BMI), smoking use] and operation times were recorded. All patients were administered 1000 mg parol IV as standard analgesic before extubation. The patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment. |
| Group D | Experimental | Procedure: Dexmedetomidin + bupivacaineGroup D (adjuvant dexmedetomidine): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 0.5 mcg/kg and (maximum 50 mcg) dexmedetomidine. All patients were administered 1000 mg parol IV as standard analgesic before extubation. The patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies. The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. VAS 0-2: no pain, 3-4: mild pain, 5-6: moderate pain, 7-8: severe pain, 9-10: excruciating pain. Additional analgesic requirement in the postoperative period was calculated by measuring VAS>4 values. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20-60 years old
- Those who will undergo elective laparoscopic cholecystectomy surgery
- Those in ASA I-II physical status
- Those who gave consent to participate in the study
Key exclusion criteria (15 listed)
- Those outside the age range of 20-60
- Those outside of ASA I-II physical status
- Serious heart, lung, liver disease
- Kidney failure
- Bleeding diathesis
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 |
|---|---|---|
| Dexmedetomidin + bupivacainedexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP) | Procedure or surgery | Group D |
| Tramadol + Bupivacainetramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP) | Drug | Group T |
Primary outcome
intraoperative non invasive blood pressure
Time frame: 10 minutes
non invasive blood pressure(systolic, diastolic and mean blood pressure)
intraoperative opioid consumption
Time frame: 40 minutes
The necessary opioid (mcg) addiction was noted
intraoperative muscle relaxant use
Time frame: 40 minutes
The necessary muscle relaxant (mg) addiction was noted
intraoperative heart rate
Time frame: 5 minutes
Heart rate was noted
2 secondary outcomes
postoperative analgesic effects
Time frame: 0., 3., 6. hour measurements were evaluated
Number of participants with postoperative side effects
Time frame: 0., 3., 6. hour measurements were evaluated
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 15 Jun 2023.
- Derived from this study: PubMed 38002616Korkutata Z, Tekeli AE, Kurt N. Intraoperative and Postoperative Effects of Dexmedetomidine and Tramadol Added as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block. J Clin Med. 2023 Nov 9;12(22):7001. doi: 10.3390/jcm12227001.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
School of Medicine Department of Anesthesiology and Reanimation study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidin + bupivacaine and Tramadol + Bupivacaine in people with Transversus Abdominis Plane Block, run by Yuzuncu Yil 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 4 inclusion and 15 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 15 Jun 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?
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?
intraoperative non invasive blood pressure (time frame: 10 minutes). The study lists 4 primary outcomes in all. 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 NCT05905757, 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 15 Jun 2023.