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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine group | Active Comparator | Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone. |
|
| pethidine plus dexamethasone group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | intrathecal injection of bupivacaine alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Time of the first need for Rescue Analgesia | 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. | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative changes in the blood pressure measurements (The incidence of hypotension ) | The incidence of hypotension "defined as the mean arterial blood pressure decreased by > 20 % from its value before intrathecal injection of the study drugs" | duration of the procedure |
| Intraoperative changes in the heart rate measurements (The incidence of bradycardia) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salwa S ElSherbeny, Lecturer | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine , Zagazig University | Zagazig | Sharqia Province | 44511 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008614 | Meperidine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Pethidine plus Dexamethasone | Drug | Intrathecal injection of pethidine plus dexamethasone |
|
|
bradycardia "defined as the reduction of heart rate by > 20% of the basal reading". |
| duration of the procedure |
| The onset of the sensory block | 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 | duration of the procedure |
| The onset of the motor block | 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 | duration of the procedure |
| The time of regression of sensory block to the 5th lumbar dermatome | The sensory level was checked using the pinprick technique every 15 min until sensations were gained back to the 5th lumbar dermatome | Up to 12 hours postoperative |
| The time of regression of motor block to full motor function "Bromage score 0". | 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". | Up to 12 hours postoperative |
| The incidence of perioperative adverse events | Assess the frequency of perioperative nausea, vomiting, sedation, shivering, pruritis, and respiratory depression. | duration of the procedure and 24 hours postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |