Postoperative PainPhase 4NCT05303311
Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries
A Phase 4 study testing Bupivacaine Hydrochloride and Pethidine plus Dexamethasone in people with Postoperative Pain, run by Zagazig University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine Hydrochloride and Pethidine plus Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 15 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine , Zagazig University
Zagazig, Sharqia Province, 44511
About this study
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.
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
Read the 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
- Postoperative Pain
- Being tested
- Bupivacaine Hydrochloride, Pethidine plus Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called Heavy marcaine
intrathecal injection of bupivacaine alone
Pethidine plus DexamethasoneDrug
Also called meperidine and decadron
Intrathecal injection of pethidine plus dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Active comparator | Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone. Receives: Drug: Bupivacaine Hydrochloride |
| pethidine plus dexamethasone group | Active comparator | 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 Receives: Drug: Pethidine plus Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperative
Secondary outcomes (7)
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"
Measured: 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".
Measured: 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
Measured: 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
Measured: 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
Measured: 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".
Measured: Up to 12 hours postoperative
The incidence of perioperative adverse events
Assess the frequency of perioperative nausea, vomiting, sedation, shivering, pruritis, and respiratory depression.
Measured: duration of the procedure and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Jan 2022
- Primary completion15 Jan 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Salwa Samir El Sherbeny, Zagazig University
- Investigators
- Salwa S ElSherbeny, Lecturer, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303311
- Sponsor's protocol ID
- 8035-7-11-2021
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05303311
- Acronym / sponsor ID
- 8035-7-11-2021
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Active comparator | Drug: Bupivacaine HydrochloridePatients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone. |
| pethidine plus dexamethasone group | Active comparator | Drug: Pethidine plus DexamethasonePatients 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine HydrochlorideAlso: Heavy marcaineintrathecal injection of bupivacaine alone | Drug | Bupivacaine group |
| Pethidine plus DexamethasoneAlso: meperidine and decadronIntrathecal injection of pethidine plus dexamethasone | Drug | pethidine plus dexamethasone group |
Primary outcome
The Time of the first need for Rescue Analgesia
Time frame: 24 hours postoperative
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.
7 secondary outcomes
Intraoperative changes in the blood pressure measurements (The incidence of hypotension )
Time frame: duration of the procedure
Intraoperative changes in the heart rate measurements (The incidence of bradycardia)
Time frame: duration of the procedure
The onset of the sensory block
Time frame: duration of the procedure
The onset of the motor block
Time frame: duration of the procedure
The time of regression of sensory block to the 5th lumbar dermatome
Time frame: Up to 12 hours postoperative
The time of regression of motor block to full motor function "Bromage score 0".
Time frame: Up to 12 hours postoperative
The incidence of perioperative adverse events
Time frame: duration of the procedure and 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salwa S ElSherbeny, Lecturer principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Hydrochloride and Pethidine plus Dexamethasone in people with Postoperative Pain, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Time of the first need for Rescue Analgesia (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.