Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2024-03-15

Brief Summary

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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

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Detailed Description

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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

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Bupivacaine group

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

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

intrathecal injection of bupivacaine alone

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

Group Type ACTIVE_COMPARATOR

Pethidine plus Dexamethasone

Intervention Type DRUG

Intrathecal injection of pethidine plus dexamethasone

Interventions

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Bupivacaine Hydrochloride

intrathecal injection of bupivacaine alone

Intervention Type DRUG

Pethidine plus Dexamethasone

Intrathecal injection of pethidine plus dexamethasone

Intervention Type DRUG

Other Intervention Names

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Heavy marcaine meperidine and decadron

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes