Clinical Trials Directory

Trials / Completed

CompletedNCT05303311

Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries

Comparing the Analgesic Properties of Intrathecal Pethidine Plus Dexamethasone Versus Intrathecal Bupivacaine Alone for Distal Lower Extremity Orthopedic Surgeries: A Randomized Comparative Study.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGBupivacaine Hydrochlorideintrathecal injection of bupivacaine alone
DRUGPethidine plus DexamethasoneIntrathecal injection of pethidine plus dexamethasone

Timeline

Start date
2022-01-15
Primary completion
2024-01-15
Completion
2024-03-15
First posted
2022-03-31
Last updated
2024-07-30

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05303311. Inclusion in this directory is not an endorsement.