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Clinical Trials/NCT01929252
NCT01929252CompletedPhase 4

Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy

TC Erciyes University1 site in 1 country50 target enrollmentStarted: August 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Analgesic Consumption

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dexmedetomidine

Active Comparator

%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.

Intervention: Dexmedetomidine (Drug)

Dexmedetomidine

Active Comparator

%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.

Intervention: Levobupivacaine (Drug)

Levobupivacaine

Active Comparator

%0.25 40 ml levobupivacaine administered via wound infiltration prior to incision.

Intervention: Levobupivacaine (Drug)

Outcomes

Primary Outcomes

Analgesic Consumption

Time Frame: 1 day after surgery

Pethidine consumption (patient controlled analgesia procedure) was recorded

Secondary Outcomes

  • Visual Analog Scale(1 day after surgery)
  • Haemodynamic Changes(During the surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayse Ulgey

Assistant Professor

TC Erciyes University

Study Sites (1)

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