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.

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Pethidine plus Dexamethasone

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

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44511
      • Faculty of Medicine , Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine group; Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.	Drug: Bupivacaine Hydrochloride; intrathecal injection of bupivacaine alone; Other Names: Heavy marcaine
Active Comparator: 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	Drug: Pethidine plus Dexamethasone; Intrathecal injection of pethidine plus dexamethasone; Other Names: meperidine and decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	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".	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	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	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	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".	Up to 12 hours postoperative
The incidence of perioperative adverse events	Assess the frequency of perioperative nausea, vomiting, sedation, shivering, pruritis, and respiratory depression.	duration of the procedure and 24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Salwa S ElSherbeny, Lecturer, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 20, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Dexamethasone; Bupivacaine; Meperidine
• Other Study ID Numbers: 8035-7-11-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No