Intrathecal Injection of Pethidine Plus Dexamethasone Versus Bupivacaine Alone
Primary Purpose
Postoperative Pain
Status
Active
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Pethidine plus Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
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).
Sites / Locations
- Faculty of Medicine , Zagazig University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bupivacaine group
pethidine plus dexamethasone group
Arm Description
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.
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
Outcomes
Primary Outcome Measures
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
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
Level of sensory block
assess the level of sensory block in both groups after spinal anaesthesia using the pinprick technique
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)
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
intraoperative complication
assess the frequency of Intraoperative nausea, vomiting, shivering, pruritis and respiratory depression
Secondary Outcome Measures
analgesic requirements
Postoperative analgesic requirements regarding the time of its need and the dose required to achieve the desired analgesia.
Incidence of postoperative nausea and vomiting.
Comparing the incidence of nausea and vomiting postoperatively in both groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05303311
Brief Title
Intrathecal Injection of Pethidine Plus Dexamethasone Versus Bupivacaine Alone
Official Title
Intrathecal Injection of Pethidine and Dexamethasone Versus Intrathecal Injection of Bupivacaine in Lower Extremity Orthopedic Surgeries: Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine group
Arm Type
Active Comparator
Arm Description
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.
Arm Title
pethidine plus dexamethasone group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
Heavy marcaine
Intervention Description
intrathecal injection of bupivacaine alone
Intervention Type
Drug
Intervention Name(s)
Pethidine plus Dexamethasone
Other Intervention Name(s)
meperidine and decadron
Intervention Description
Intrathecal injection of pethidine plus dexamethasone
Primary Outcome Measure Information:
Title
changes in the blood pressure measurements
Description
monitoring intraoperative changes in the blood pressure (BP) measured by mmHg and comparing it with the preoperative measures in both groups
Time Frame
duration of the procedure
Title
changes in the heart rate measurements
Description
monitoring intraoperative changes in the heart rate measured by beat per minute (BPM) and comparing it with the preoperative measures in both groups
Time Frame
duration of the procedure
Title
Level of sensory block
Description
assess the level of sensory block in both groups after spinal anaesthesia using the pinprick technique
Time Frame
duration of the procedure
Title
Level of motor block
Description
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)
Time Frame
duration of the procedure
Title
Amount of sedative medications needed
Description
assess the need for intraoperative sedative medications as benzodiazepines and measure it by (mg/kg) or ketamine (measured by mg/kg) in both groups
Time Frame
duration of the procedure
Title
intraoperative complication
Description
assess the frequency of Intraoperative nausea, vomiting, shivering, pruritis and respiratory depression
Time Frame
duration of the procedure
Secondary Outcome Measure Information:
Title
analgesic requirements
Description
Postoperative analgesic requirements regarding the time of its need and the dose required to achieve the desired analgesia.
Time Frame
at 0, 3, 6, 12, 24 hours postoperative
Title
Incidence of postoperative nausea and vomiting.
Description
Comparing the incidence of nausea and vomiting postoperatively in both groups
Time Frame
at 0, 3, 6, 12, 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salwa S ElSherbeny, Lecturer
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine , Zagazig University
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44511
Country
Egypt
12. IPD Sharing Statement
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Intrathecal Injection of Pethidine Plus Dexamethasone Versus Bupivacaine Alone
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