Pain, PostoperativePhase 3NCT06319859
Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries
A Phase 3 study testing Morphine in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.
Trial summary
This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2024to 25 Nov 2025
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years old.
- Both genders.
- ASA I and II class.
Who cannot join
- Patient refusal.
- Known local anesthetic (LA) allergy.
- Skin lesions or infections at the site of needle insertion.
- Contraindications to spinal anesthesia.
- Failure of spinal anesthesia.
- ASA III and VI class.
- Central or peripheral neuropathies.
- Severe respiratory or cardiac diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.
This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.
- Conditions
- Pain, Postoperative
- Being tested
- Morphine, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
The patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally
PlaceboDrug
The patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally Receives: Drug: Morphine |
| Group B | Active comparator | patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic requirement
The time to first analgesic required by the patient will be recorded
Measured: 48 hours post-operatively
Secondary outcomes (3)
Nalbuphine consumption
The amount of nalbuphine consumption as postoperative analgesia
Measured: 48 hours post-operatively
Postoperative pain
Postoperative pain at rest and movement by numeric rating scale Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Measured: at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively
The incidence of other adverse effects
The incidence of other adverse effects e.g. neurotoxicity, respiratory depression, nausea, vomiting, urine retention and pruritus will be recorded
Measured: 14 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Aug 2024
- Primary completion15 Oct 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319859
- Sponsor's protocol ID
- N-72-2024
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2024
- Last updated
- 5 Dec 2025
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06319859
- Acronym / sponsor ID
- N-72-2024
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 20 Mar 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.
This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Morphinepatients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally |
| Group B | Active comparator | Drug: Placebopatients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years old.
- Both genders.
- ASA I and II class.
Key exclusion criteria (8 listed)
- Patient refusal.
- Known local anesthetic (LA) allergy.
- Skin lesions or infections at the site of needle insertion.
- Contraindications to spinal anesthesia.
- Failure of spinal anesthesia.
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 |
|---|---|---|
| MorphineThe patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally | Drug | Group A |
| PlaceboThe patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally | Drug | Group B |
Primary outcome
Time to first analgesic requirement
Time frame: 48 hours post-operatively
The time to first analgesic required by the patient will be recorded
3 secondary outcomes
Nalbuphine consumption
Time frame: 48 hours post-operatively
Postoperative pain
Time frame: at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively
The incidence of other adverse effects
Time frame: 14 days post-operatively
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 5 Dec 2025.
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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 Phase 3 study testing Morphine in people with Pain, Postoperative, run by Cairo 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 8 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 5 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to first analgesic requirement (time frame: 48 hours post-operatively). 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 5 Dec 2025.