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

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.

Study Overview

• Status: Completed
• Conditions: Transversus Abdominis Plane Block
• Intervention / Treatment: Drug: Tramadol + Bupivacaine; Procedure: Dexmedetomidin + bupivacaine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65100
    • Van Yuzuncu Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tramadol + Bupivacaine; tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)
Experimental: 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.	Procedure: Dexmedetomidin + bupivacaine; dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative non invasive blood pressure	non invasive blood pressure(systolic, diastolic and mean blood pressure)	10 minutes
intraoperative opioid consumption	The necessary opioid (mcg) addiction was noted	40 minutes
intraoperative muscle relaxant use	The necessary muscle relaxant (mg) addiction was noted	40 minutes
intraoperative heart rate	Heart rate was noted	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	0., 3., 6. hour measurements were evaluated

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Chair: School of Medicine Department of Anesthesiology and Reanimation, Van Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): April 3, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: adjuvant; Dexmedetomidine; Transversus abdominis plane block; Tramadol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine; Tramadol
• Other Study ID Numbers: 2023/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No