Clinical trial NCT05303311: Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries
Official title: Comparing the Analgesic Properties of Intrathecal Pethidine Plus Dexamethasone Versus Intrathecal Bupivacaine Alone for Distal Lower Extremity Orthopedic Surgeries: A Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-03-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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).

Primary outcomes:
measure: The Time of the first need for Rescue Analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Intraoperative changes in the blood pressure measurements (The incidence of hypotension )
timeFrame: duration of the procedure
measure: Intraoperative changes in the heart rate measurements (The incidence of bradycardia)
timeFrame: duration of the procedure
measure: The onset of the sensory block
timeFrame: duration of the procedure
measure: The onset of the motor block
timeFrame: duration of the procedure
measure: The time of regression of sensory block to the 5th lumbar dermatome
timeFrame: Up to 12 hours postoperative
measure: The time of regression of motor block to full motor function "Bromage score 0".
timeFrame: Up to 12 hours postoperative
measure: The incidence of perioperative adverse events
timeFrame: duration of the procedure and 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine , Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Salwa S ElSherbeny, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: