Intrathecal Injection of Pethidine Plus Dexamethasone Versus Bupivacaine Alone

Postoperative Pain Clinical Trial

Official title:

Intrathecal Injection of Pethidine and Dexamethasone Versus Intrathecal Injection of Bupivacaine in Lower Extremity Orthopedic Surgeries: Comparative Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05303311
• Other study ID #: 8035-7-11-2021
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 15, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine Hydrochloride
intrathecal injection of bupivacaine alone
• Pethidine plus Dexamethasone
Intrathecal injection of pethidine plus dexamethasone

Locations

Country	Name	City	State
Egypt	Faculty of Medicine , Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the blood pressure measurements	monitoring intraoperative changes in the blood pressure (BP) measured by mmHg and comparing it with the preoperative measures in both groups	duration of the procedure
Primary	changes in the heart rate measurements	monitoring intraoperative changes in the heart rate measured by beat per minute (BPM) and comparing it with the preoperative measures in both groups	duration of the procedure
Primary	Level of sensory block	assess the level of sensory block in both groups after spinal anaesthesia using the pinprick technique	duration of the procedure
Primary	Level of motor block	assess the level of motor block in both groups after spinal anaesthesia using Bromage scale where grade 1 means (free movement of legs and feet) and grade 4 means (patient is unable to move legs or feet)	duration of the procedure
Primary	Amount of sedative medications needed	assess the need for intraoperative sedative medications as benzodiazepines and measure it by (mg/kg) or ketamine (measured by mg/kg) in both groups	duration of the procedure
Primary	intraoperative complication	assess the frequency of Intraoperative nausea, vomiting, shivering, pruritis and respiratory depression	duration of the procedure
Secondary	analgesic requirements	Postoperative analgesic requirements regarding the time of its need and the dose required to achieve the desired analgesia.	at 0, 3, 6, 12, 24 hours postoperative
Secondary	Incidence of postoperative nausea and vomiting.	Comparing the incidence of nausea and vomiting postoperatively in both groups	at 0, 3, 6, 12, 24 hours postoperative