A Phase 4 interventional study of Bupivacaine Hydrochloride and Pethidine plus Dexamethasone in Postoperative Pain, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Zagazig University · Phase 4, Interventional, and Treatment
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
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 46 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.
Drug: Bupivacaine Hydrochloride
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
Drug: Pethidine plus Dexamethasone
intrathecal injection of bupivacaine alone
Also known as: Heavy marcaine
Intrathecal injection of pethidine plus dexamethasone
Also known as: meperidine and decadron
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.
Time frame: 24 hours postoperative
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"
Time frame: duration of the procedure
Intraoperative changes in the heart rate measurements (The incidence of bradycardia)
bradycardia "defined as the reduction of heart rate by \> 20% of the basal reading".
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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".
Time frame: Up to 12 hours postoperative
The incidence of perioperative adverse events
Assess the frequency of perioperative nausea, vomiting, sedation, shivering, pruritis, and respiratory depression.
Time frame: duration of the procedure and 24 hours postoperative
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Zagazig University