Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- TC Erciyes University
- 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
%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.
Intervention: Dexmedetomidine (Drug)
Dexmedetomidine
%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.
Intervention: Levobupivacaine (Drug)
Levobupivacaine
%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
Ayse Ulgey
Assistant Professor
TC Erciyes University
