Comparing the Analgesic Properties of Intrathecal Pethidine Plus Dexamethasone Versus Intrathecal Bupivacaine Alone for Distal Lower Extremity Orthopedic Surgeries: A Randomized Comparative Study.
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine Hydrochloride
- Conditions
- Postoperative Pain
- Sponsor
- Zagazig University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- The Time of the first need for Rescue Analgesia
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Bupivacaine is commonly used as a sole agent for spinal anesthesia unlike pethidine. Pethidine (meperidine) is a unique opioid. In addition to its analgesic activity, it also has significant local anesthetic activity. This property enables it to be used as the sole agent for spinal anesthesia
Detailed Description
pethidine compared favorably with bupivacaine as the sole anesthetic agent, providing excellent conditions for lower abdominal and pelvic surgery. Some studies showed that intrathecal pethidine has short motor recovery and prolonged postoperative analgesia in comparison to intrathecal bupivacaine. The side effects of pethidine in spinal anesthesia are pruritus nausea, vomiting and respiratory depression. A dose of 1mg/kg intrathecal pethidine provides surgical anesthesia .However, its effects are not widely available in recent studies. Dexamethasone is used as an adjuvant to local anesthetic during spinal anesthesia and other techniques of regional anesthesia, it reduces pain and prolongs the duration of post-operative analgesia. It was shown that intrathecal dexamethasone reduces the complications of spinal anesthesia such as arterial hypotension, nausea, vomiting and shivering. The investigators suppose that addition of intrathecal dexamethasone to pethidine may be a better alternative to intrathecal bupivacaine during spinal anesthesia for lower extremity orthopedic surgery with better outcome and less side effects
Investigators
Salwa Samir El Sherbeny
Lecturer of Anesthesia, Intensive Care and pain management, Faculty of Medicine, Zagazig University
Zagazig University
Eligibility Criteria
Inclusion Criteria
- •Patient acceptance.
- •Patients scheduled for lower extremity orthopedic surgery
- •Patient's age \>18 years.
- •Patients with American Society of Anaesthesia (ASA)physical status I, II.
Exclusion Criteria
- •Patient's age ≤18 years.
- •Uncooperative patients and patients with psychological problems.
- •Patients with contraindications to spinal anesthesia.
- •Patients with contraindications to bupivacaine or dexamethasone or pethidine.
- •Patients with ASA physical status III and IV.
- •Morbid obesity (BMI \>35).
Arms & Interventions
Bupivacaine group
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.
Intervention: Bupivacaine Hydrochloride
pethidine plus dexamethasone group
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 1mg/kg preservative-free pethidine plus 4mg dexamethasone diluted to a volume of 3 ml with 0.9% sodium chloride
Intervention: Pethidine plus Dexamethasone
Outcomes
Primary Outcomes
The Time of the first need for Rescue Analgesia
Time Frame: 24 hours postoperative
the time from the end of the intrathecal injection of the study drugs to the first report of pain that reached NRS 4 as described by the patient.
Secondary Outcomes
- Intraoperative changes in the blood pressure measurements (The incidence of hypotension )(duration of the procedure)
- Intraoperative changes in the heart rate measurements (The incidence of bradycardia)(duration of the procedure)
- The onset of the sensory block(duration of the procedure)
- The onset of the motor block(duration of the procedure)
- The incidence of perioperative adverse events(duration of the procedure and 24 hours postoperative)
- The time of regression of sensory block to the 5th lumbar dermatome(Up to 12 hours postoperative)
- The time of regression of motor block to full motor function "Bromage score 0".(Up to 12 hours postoperative)