Postoperative Analgesia
Conditions
Brief summary
A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
Detailed description
Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position. Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
Interventions
DRUGDexmedetomidine
INTRATHECAL AND INTRAVENOUS
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-II patients * age 18-65 years * scheduled for lower limb surgery * spinal anaesthesia
Exclusion criteria
* patients with coagulopathy * infection at the site of lumbar puncture * beta-blockers or calcium channel blockers usage * hypersensitivity to Bupivacaine or Dexmedetomidine * any other contra-indications for spinal anaesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First request to analgesia | Postoperative up to 24 hours | The first time the patient is asking for analgesia to control his pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative analgesia consumption | Postoperative up to 24 hours | Total consumption of analgesia to control pain |
| visual analogue scale | Every two hours for 24 hours postoperative | The score subjectively measures the severity of pain and it is ranging from 0 when there is no pain to 10 when it is the worse pain imaginable |
Countries
Egypt
Outcome results
None listed