Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

NCT ID: NCT05905757

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-04-03

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.

Conditions

Transversus Abdominis Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Group T

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.

Group Type: EXPERIMENTAL

Tramadol + Bupivacaine

Intervention Type: DRUG

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

Group D

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.

Group Type: EXPERIMENTAL

Dexmedetomidin + bupivacaine

Intervention Type: PROCEDURE

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

Interventions

Dexmedetomidin + bupivacaine

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

Intervention Type: PROCEDURE

Tramadol + Bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Esen Tekeli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

School of Medicine Department of Anesthesiology and Reanimation

Role: STUDY_CHAIR

Yuzuncu Yıl University

Locations

Van Yuzuncu Yil University

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 38002616 (View on PubMed)

Other Identifiers

2023/2

Identifier Type: -

Identifier Source: org_study_id