Postoperative PainNCT06818396
Analgesic Efficacy of Fascia Iliaca Compartment Block Compared With Intrathecal Nalbuphine for Hip Surgery Under Spinal Anesthesia
A study testing US-guided fascia iliaca compartment block (FICB) and spinal anesthesia, Intrathecal nalbuphine and spinal anesthesia and Spinal anesthesia in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
It is already known that fascia iliaca compartment block and intrathecal nalbuphine are very effective ways in postoperative pain control in patients having hip surgeries. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- US-guided fascia iliaca compartment block (FICB) and spinal anesthesia, Intrathecal nalbuphine and spinal anesthesia and Spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) score (ASA I- ASA II).
- Age ≥ 21years.
- Body mass index < 35 kg/m2
Who cannot join
- Patient's refusal.
- Known coagulopathy.
- Known peripheral neuropathy or neurological deficits.
- Known allergy to study drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain-Shams University Hospitals
Cairo
Ibrahim Mamdouh Esmat, 01001241928, ibrahim_mamdouh@med.asu.edu.eg
About this study
Official title: Analgesic Efficacy of Fascia Iliaca Compartment Block Compared With Intrathecal Nalbuphine for Hip Surgery Under Spinal Anesthesia: a Randomized Controlled Trial
It is already known that fascia iliaca compartment block and intrathecal nalbuphine are very effective ways in postoperative pain control in patients having hip surgeries.
- Conditions
- Postoperative Pain
- Being tested
- US-guided fascia iliaca compartment block (FICB) and spinal anesthesia, Intrathecal nalbuphine and spinal anesthesia, Spinal anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided fascia iliaca compartment block (FICB) and spinal anesthesiaOther
US-guided fascia iliaca compartment block (FICB) and spinal anesthesia
Intrathecal nalbuphine and spinal anesthesiaDrug
intrathecal nalbuphine and spinal anesthesia
Spinal anesthesiaOther
Spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| US-guided fascia iliaca compartment block (FICB) and spinal anesthesia | Active comparator | Not described Receives: Other: US-guided fascia iliaca compartment block (FICB) and spinal anesthesia |
| Intrathecal nalbuphine and spinal anesthesia | Active comparator | Not described Receives: Drug: Intrathecal nalbuphine and spinal anesthesia |
| Spinal anesthesia | Other | Not described Receives: Other: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia (minutes).
Time to first rescue analgesia (minutes).
Measured: in the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start18 Feb 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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 Ain Shams 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818396
- Sponsor's protocol ID
- FMASU-MS 72 / 2025
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 15 Jun 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Fascia Iliaca Compartment Block Compared With Intrathecal Nalbuphine for Hip Surgery Under Spinal Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06818396
- Acronym / sponsor ID
- FMASU-MS 72 / 2025
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
It is already known that fascia iliaca compartment block and intrathecal nalbuphine are very effective ways in postoperative pain control in patients having hip surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| US-guided fascia iliaca compartment block (FICB) and spinal anesthesia | Active comparator | Other: US-guided fascia iliaca compartment block (FICB) and spinal anesthesia |
| Intrathecal nalbuphine and spinal anesthesia | Active comparator | Drug: Intrathecal nalbuphine and spinal anesthesia |
| Spinal anesthesia | Other | Other: Spinal anesthesia |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) score (ASA I- ASA II).
- Age ≥ 21years.
- Body mass index < 35 kg/m2
Key exclusion criteria (4 listed)
- Patient's refusal.
- Known coagulopathy.
- Known peripheral neuropathy or neurological deficits.
- Known allergy to study drugs
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 |
|---|---|---|
| US-guided fascia iliaca compartment block (FICB) and spinal anesthesiaUS-guided fascia iliaca compartment block (FICB) and spinal anesthesia | Other | US-guided fascia iliaca compartment block (FICB) and spinal anesthesia |
| Intrathecal nalbuphine and spinal anesthesiaintrathecal nalbuphine and spinal anesthesia | Drug | Intrathecal nalbuphine and spinal anesthesia |
| Spinal anesthesiaSpinal anesthesia | Other | Spinal anesthesia |
Primary outcome
Time to first rescue analgesia (minutes).
Time frame: in the first 24 hours after surgery
Time to first rescue analgesia (minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided fascia iliaca compartment block (FICB) and spinal anesthesia, Intrathecal nalbuphine and spinal anesthesia and Spinal anesthesia in people with Postoperative Pain, run by Ain Shams 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 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesia (minutes). (time frame: in the first 24 hours after surgery). 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 15 Jun 2026.