Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

Transversus Abdominis Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05905757
• Other study ID #: 2023/2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 3, 2023

Study information

• Verified date: June 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 3, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Transversus Abdominis Plane Block

Intervention

Procedure:
• Dexmedetomidin + bupivacaine
dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

Drug:
• Tramadol + Bupivacaine
tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

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