Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Dexmedetomidine; Drug: Levobupivacaine

• Registration Number: NCT01929252
• Lead Sponsor: TC Erciyes University

Brief Summary

The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.

Detailed Description

Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective analgesia after hysterectomy essential and several techniques are used such as administration of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local anaesthetics. Different local anaesthetics can be used for the wound infiltration techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides pain relief in the postoperative period , allows the early discharge from the outpatient surgical units.There has been increased interest in administration of analgesic prior to surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine has been used intravenously before initiation of anaesthesia and it has shown to provide some analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic effects of intravenous administration while still providing the postoperative analgesia.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2012-08
• Status Verified: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-22
• Study First Posted: 2013-08-27
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 18-65 yo female
• scheduled for elective hysterectomy
• no known allergies to drugs
• ASA 1=2 patients

Exclusion Criteria

• history of diabetes
• history of chronic pain treatment
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.
Dexmedetomidine	Levobupivacaine	%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.
Levobupivacaine	Levobupivacaine	%0.25 40 ml levobupivacaine administered via wound infiltration prior to incision.

Primary Outcome Measures

Name	Time	Method
Analgesic Consumption	1 day after surgery	Pethidine consumption (patient controlled analgesia procedure) was recorded

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	1 day after surgery	Visual analog scale on rest and movement was recorded.
Haemodynamic Changes	During the surgery	Arterial blood pressure, heart rate, peripheral oxygen saturation

Trial Locations

Locations (1)

Erciyes university hospital; 🇹🇷 Kayseri, Turkey