Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries

Zagazig University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Pethidine plus Dexamethasone; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05303311

8035-7-11-2021

Details and patient eligibility

About

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

Full 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

Enrollment: 46 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Bupivacaine group

Active Comparator group

Description:

Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.

Treatment:

Drug: Bupivacaine Hydrochloride

pethidine plus dexamethasone group

Active Comparator group

Description:

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

Treatment:

Drug: Pethidine plus Dexamethasone