Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.

Pain Clinical Trial

Official title:

Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964586
• Other study ID #: 2013/167
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2013
• Last updated: October 15, 2013
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.

Description:

Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Scheduled for the nasal septoplasty surgery

• ASA 1-2 patients

• 18-60 yo patients

Exclusion Criteria:

• Pregnant patients

• ASA 3-4 patients

• Under 18 yo childrens

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain
• Surgery

Intervention

Drug:
• Dexmedetomidine
2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
• Lidocaine
10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
• Adrenaline
12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical conditions	Bleeding scores were recorded during the surgery	during the surgery	No
Secondary	Analgesic Consumption	Analgesic consumption were recorded.	Up to 24 hours	No