Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

Yuzuncu Yıl University

Status: Completed

Conditions: Transversus Abdominis Plane Block

Treatments: Drug: Tramadol + Bupivacaine; Procedure: Dexmedetomidin + bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05905757

2023/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Group T

Experimental group

Description:

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.

Treatment:

Drug: Tramadol + Bupivacaine

Group D

Experimental group

Description:

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.

Treatment:

Procedure: Dexmedetomidin + bupivacaine