Postoperative Pain
Conditions
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
Interventions
DRUGBupivacaine Hydrochloride
intrathecal injection of bupivacaine alone
Intrathecal injection of pethidine plus dexamethasone
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient acceptance. * Patients scheduled for lower extremity orthopedic surgery * Both sex * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time of the first need for Rescue Analgesia | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative changes in the blood pressure measurements (The incidence of hypotension ) | duration of the procedure | The incidence of hypotension defined as the mean arterial blood pressure decreased by \> 20 % from its value before intrathecal injection of the study drugs |
| Intraoperative changes in the heart rate measurements (The incidence of bradycardia) | duration of the procedure | bradycardia defined as the reduction of heart rate by \> 20% of the basal reading. |
| The onset of the sensory block | duration of the procedure | The sensory level was checked using the pinprick technique every min for 10 min then at 2-min intervals until a constant block was obtained |
| The onset of the motor block | duration of the procedure | The Motor Block was checked using Modified Bromage Score Bromage 0 means full movement of the hip, knee, and ankle, Bromage 1 means loss of the ability to raise the leg against gravity but able to bend the knee and the ankle joints, Bromage 2 lost the ability to flex the hip and knee joints but preserved flexion of the ankle, Bromage 3 lost the ability to flex the hip, knee, and ankle joints but preserved movement of the toes, Bromage 4 indicates full paralysis of the legs. every min for 10 min then at 2-min intervals until a Bromage score 4 was obtained |
| The time of regression of sensory block to the 5th lumbar dermatome | Up to 12 hours postoperative | The sensory level was checked using the pinprick technique every 15 min until sensations were gained back to the 5th lumbar dermatome |
| The time of regression of motor block to full motor function Bromage score 0. | Up to 12 hours postoperative | The Motor Block was checked using Modified Bromage Score every 15 min until full motor function was restored. Bromage score 0...... Modified Bromage Score: Bromage 0 means full movement of the hip, knee, and ankle, Bromage 1 means loss of the ability to raise the leg against gravity but able to bend the knee and the ankle joints, Bromage 2 lost the ability to flex the hip and knee joints but preserved flexion of the ankle, Bromage 3 lost the ability to flex the hip, knee, and ankle joints but preserved movement of the toes, Bromage 4 indicates full paralysis of the legs. |
| The incidence of perioperative adverse events | duration of the procedure and 24 hours postoperative | Assess the frequency of perioperative nausea, vomiting, sedation, shivering, pruritis, and respiratory depression. |
Countries
Egypt
Outcome results
None listed