Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

NCT05905757 | Completed

• 1 other identifier: 2023/2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Transversus Abdominis Plane Block

Keywords

Transversus abdominis plane block; adjuvant; Dexmedetomidine; Tramadol

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• postoperative analgesic effects

  0., 3., 6. hour measurements were evaluated

• Number of participants with postoperative side effects

  0., 3., 6. hour measurements were evaluated

Study Arms (2)

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.

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.

Procedure: Dexmedetomidin + bupivacaine

Interventions

Dexmedetomidin + bupivacaine PROCEDURE

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

Group D

Tramadol + Bupivacaine DRUG

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

Group T

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, 65100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38002616 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Tramadol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• School of Medicine Department of Anesthesiology and Reanimation

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective randomized controlled trial

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 15, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 3, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)