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Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05905757
Enrollment
60
Registered
2023-06-15
Start date
2022-03-01
Completion date
2023-04-03
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transversus Abdominis Plane Block

Keywords

Transversus abdominis plane block, adjuvant, Dexmedetomidine, Tramadol

Brief 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.

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.

Interventions

PROCEDUREDexmedetomidin + bupivacaine

dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

DRUGTramadol + Bupivacaine

tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Intervention model description

prospective randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
intraoperative non invasive blood pressure10 minutesnon invasive blood pressure(systolic, diastolic and mean blood pressure)
intraoperative opioid consumption40 minutesThe necessary opioid (mcg) addiction was noted
intraoperative muscle relaxant use40 minutesThe necessary muscle relaxant (mg) addiction was noted
intraoperative heart rate5 minutesHeart rate was noted

Secondary

MeasureTime frameDescription
postoperative analgesic effects0., 3., 6. hour measurements were evaluatedVisual analogue scale (VAS) scores were noted.pointed between 0-10. 0:No pain, 5-6-7:medium pain, 9-10:unbearable pain
Number of participants with postoperative side effects0., 3., 6. hour measurements were evaluatednausea, vomiting, chills. Patients with these effects were noted. Evaluated by the number of people

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026