Post Operative PainNCT06625606
Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery
A study testing Bupivacaine 0.5% Injectable Solution and Isoflurane Inhalant Product in people with Post Operative Pain, run by Benha University at 1 site in Egypt.
Trial summary
A study was conducted to compare the effectiveness of continuous spinal anesthesia (CSA), single-shot spinal anesthesia (SSSA), and general anesthesia (GA) in patients over 60 years of age undergoing elective surgical repair of a fractured neck of femur. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Bupivacaine 0.5% Injectable Solution and Isoflurane Inhalant Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 1 Dec 2024
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) grade ≤III;
- Patients were assigned for elective surgical intervention for Fixation of Neck Femur;
- Patients were free of exclusion criteria.
Who cannot join
- Patients of American Society of Anesthesiologists (ASA) grade >III;
- Patients who had uncontrolled hypertension and/or diabetes mellitus;
- Patients who had uncompensated cardiac, renal, or hepatic diseases;
- Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
- Patients who refused to sign the informed consent were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Spinal Anesthesia for Patients Planned For Major Orthopedic Surgeries: Versus Single-Shot Spinal Anesthesia: A Case-Control Comparative Study
A study was conducted to compare the effectiveness of continuous spinal anesthesia (CSA), single-shot spinal anesthesia (SSSA), and general anesthesia (GA) in patients over 60 years of age undergoing elective surgical repair of a fractured neck of femur. One hundred and five patients were randomly assigned to one of the three groups. The SSSA group received a single intrathecal injection of isobaric bupivacaine 0.5%, while the CSA group received multiple injections of the same anesthetic through a catheter placed in the subarachnoid space. The GA group received isoflurane anesthesia. Intraoperatively, blood pressure was monitored to assess the frequency of hypotension and the required dose of ephedrine. Additionally, the total dose of bupivacaine administered and the frequency of intraoperative fentanyl were recorded. Postoperatively, the duration of postoperative analgesia, pain scores, and need for additional pain medication were evaluated.
- Conditions
- Post Operative Pain
- Being tested
- Bupivacaine 0.5% Injectable Solution, Isoflurane Inhalant Product
- 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 0.5% Injectable SolutionDrug
The patient's back was prepared for surgery. They were positioned on their side, with the operative side facing upward. The L3-4 spinal interspace was identified, and numbed, and a thin spinal needle was inserted. After confirming Cerebrospinal Fluid (CSF), 12.5 mg of isobaric bupivacaine 0.5% was injected into the spinal canal.
Bupivacaine 0.5% Injectable SolutionDrug
The L3-4 spinal interspace was identified, numbed, and a thicker needle (Tuohy needle) was inserted. After confirming Cerebrospinal Fluid (CSF), a thin catheter was inserted into the spinal canal and secured. An initial dose of 1 ml isobaric bupivacaine 0.5% was injected, followed by additional doses as needed to maintain the block height.
Isoflurane Inhalant ProductDrug
General anesthesia was initiated with propofol and rocuronium. Anesthesia was maintained with isoflurane, with additional rocuronium and fentanyl as needed. Breathing was controlled by the ventilator, and muscle relaxation was reversed at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Single-shot spinal anesthesia (SSSA) | Active comparator | The patient's back was prepared for surgery. They were positioned on their side, with the operative side facing upward. A thin spinal needle was inserted into the L3-4 spinal interspace, after numbing the area. Once cerebrospinal fluid was confirmed, a small dose of isobaric bupivacaine was injected into the spinal canal. Receives: Drug: Bupivacaine 0.5% Injectable Solution |
| Continuous spinal anesthesia (CSA) | Active comparator | A thicker needle was inserted into the L3-4 spinal interspace. After confirming cerebrospinal fluid, a thin catheter was inserted into the spinal canal and secured. An initial dose of isobaric bupivacaine was injected, followed by additional doses as needed to maintain the block height. Receives: Drug: Bupivacaine 0.5% Injectable Solution |
| General anesthesia | Active comparator | General anesthesia was initiated with propofol and rocuronium. Anesthesia was maintained with isoflurane, with additional rocuronium and fentanyl as needed. Breathing was controlled by the ventilator, and muscle relaxation was reversed at the end of surgery. Receives: Drug: Isoflurane Inhalant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post orthopedic surgery.
Value of Continuous Spinal Anesthesia in Pain Reduction Post-operative manifested by Total dose of Post Operative analgesia.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start10 Sep 2024
- Primary completion15 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M Elafifi, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625606
- Sponsor's protocol ID
- RC 5/9/2024
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2024
- Last updated
- 31 Mar 2026
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Spinal Anesthesia for Patients Planned For Major Orthopedic Surgeries: Versus Single-Shot Spinal Anesthesia: A Case-Control Comparative Study
- ClinicalTrials.gov ID
- NCT06625606
- Acronym / sponsor ID
- RC 5/9/2024
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Oct 2024 (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.
A study was conducted to compare the effectiveness of continuous spinal anesthesia (CSA), single-shot spinal anesthesia (SSSA), and general anesthesia (GA) in patients over 60 years of age undergoing elective surgical repair of a fractured neck of femur. One hundred and five patients were randomly assigned to one of the three groups. The SSSA group received a single intrathecal injection of isobaric bupivacaine 0.5%, while the CSA group received multiple injections of the same anesthetic through a catheter placed in the subarachnoid space. The GA group received isoflurane anesthesia. Intraoperatively, blood pressure was monitored to assess the frequency of hypotension and the required dose of ephedrine. Additionally, the total dose of bupivacaine administered and the frequency of intraoperative fentanyl were recorded. Postoperatively, the duration of postoperative analgesia, pain scores, and need for additional pain medication were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-shot spinal anesthesia (SSSA) | Active comparator | Drug: Bupivacaine 0.5% Injectable SolutionThe patient's back was prepared for surgery. They were positioned on their side, with the operative side facing upward. A thin spinal needle was inserted into the L3-4 spinal interspace, after numbing the area. Once cerebrospinal fluid was confirmed, a small dose of isobaric bupivacaine was injected into the spinal canal. |
| Continuous spinal anesthesia (CSA) | Active comparator | Drug: Bupivacaine 0.5% Injectable SolutionA thicker needle was inserted into the L3-4 spinal interspace. After confirming cerebrospinal fluid, a thin catheter was inserted into the spinal canal and secured. An initial dose of isobaric bupivacaine was injected, followed by additional doses as needed to maintain the block height. |
| General anesthesia | Active comparator | Drug: Isoflurane Inhalant ProductGeneral anesthesia was initiated with propofol and rocuronium. Anesthesia was maintained with isoflurane, with additional rocuronium and fentanyl as needed. Breathing was controlled by the ventilator, and muscle relaxation was reversed at the end of surgery. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of American Society of Anesthesiologists (ASA) grade ≤III;
- Patients were assigned for elective surgical intervention for Fixation of Neck Femur;
- Patients were free of exclusion criteria.
Key exclusion criteria (5 listed)
- Patients of American Society of Anesthesiologists (ASA) grade >III;
- Patients who had uncontrolled hypertension and/or diabetes mellitus;
- Patients who had uncompensated cardiac, renal, or hepatic diseases;
- Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
- Patients who refused to sign the informed consent were excluded from the study.
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 0.5% Injectable SolutionThe patient's back was prepared for surgery. They were positioned on their side, with the operative side facing upward. The L3-4 spinal interspace was identified, and numbed, and a thin spinal needle was inserted. After confirming Cerebrospinal Fluid (CSF), 12.5 mg of isobaric bupivacaine 0.5% was injected into the spinal canal. | Drug | Single-shot spinal anesthesia (SSSA) |
| Bupivacaine 0.5% Injectable SolutionThe L3-4 spinal interspace was identified, numbed, and a thicker needle (Tuohy needle) was inserted. After confirming Cerebrospinal Fluid (CSF), a thin catheter was inserted into the spinal canal and secured. An initial dose of 1 ml isobaric bupivacaine 0.5% was injected, followed by additional doses as needed to maintain the block height. | Drug | Continuous spinal anesthesia (CSA) |
| Isoflurane Inhalant ProductGeneral anesthesia was initiated with propofol and rocuronium. Anesthesia was maintained with isoflurane, with additional rocuronium and fentanyl as needed. Breathing was controlled by the ventilator, and muscle relaxation was reversed at the end of surgery. | Drug | General anesthesia |
Primary outcome
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post orthopedic surgery.
Time frame: 3 months
Value of Continuous Spinal Anesthesia in Pain Reduction Post-operative manifested by Total dose of Post Operative analgesia.
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 31 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.5% Injectable Solution and Isoflurane Inhalant Product in people with Post Operative Pain, run by Benha 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 3 inclusion and 5 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 31 Mar 2026. 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.
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?
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post orthopedic surgery. (time frame: 3 months). 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 31 Mar 2026.