Post-operative Pain ManagementPhase 2NCT05810012
Comparison of Analgesic Efficacy of PENB Block with FICB in Post Operative Hip Fracture Patients
A Phase 2 study testing PENG block and FICB Block in people with Post-operative Pain Management and Hip Fracture Surgery, run by Pain Medicine Department at 1 site in Pakistan.
Trial summary
This study was done to evaluate two different interventions for postoperative pain control in patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included in the study. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Post-operative Pain Management, Hip Fracture Surgery
- What is being tested?
- PENG block and FICB Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 31 Oct 2022
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical correction of fracture neck of femur under spinal anaesthesia
Who cannot join
- allergy to local anaesthetics
- bleeding disorders
- morbid obesity with BMI more than 35
- patients of chronic pain
- drug addiction
- psychiatric issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy of Ultrasound Guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block in Patients of Hip Fracture
This study was done to evaluate two different interventions for postoperative pain control in patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included in the study. Patients in Group P were given pericapsular nerve group (PENG) block while those in Group F were given fascia iliaca compartment block (FICB). Pain score, using Numeric Rating scale as a measurement tool, was assessed at one, six, eighteen and twenty fours after the procedure as a primary outcome. Total tramadol consumption in milligrams was recorded as a secondary outcome.
- Being tested
- PENG block, FICB Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockDrug
10ml of 0.125% isobaric bupivacaine injected
FICB BlockDrug
20ml of 0.125% isobaric bupivacaine injected
| Study group | Role | What they receive |
|---|---|---|
| PENG Block Group | Experimental | Not described Receives: Drug: PENG block |
| FICB Group | Experimental | Not described Receives: Drug: FICB Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score using Numeric Rating scale
Pain scored assessed after completion of surgery at one, six, eighteen and twenty fours
Measured: 24 hours
Secondary outcomes (1)
Total Tramadol consumption
Total Tramadol consumption In twenty four hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain ManagementStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Medicine Department
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moazzam Ali, Pain Medicine Department
- Investigators
- Moazzam Ali, Principal investigator, Pain Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810012
- Sponsor's protocol ID
- Comparison PENG versus FICB
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Ultrasound Guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block in Patients of Hip Fracture
- ClinicalTrials.gov ID
- NCT05810012
- Acronym / sponsor ID
- Comparison PENG versus FICB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pain Medicine DepartmentUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Apr 2023 (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 was done to evaluate two different interventions for postoperative pain control in patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included in the study. Patients in Group P were given pericapsular nerve group (PENG) block while those in Group F were given fascia iliaca compartment block (FICB). Pain score, using Numeric Rating scale as a measurement tool, was assessed at one, six, eighteen and twenty fours after the procedure as a primary outcome. Total tramadol consumption in milligrams was recorded as a secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG Block Group | Experimental | Drug: PENG block |
| FICB Group | Experimental | Drug: FICB Block |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- surgical correction of fracture neck of femur under spinal anaesthesia
Key exclusion criteria (6 listed)
- allergy to local anaesthetics
- bleeding disorders
- morbid obesity with BMI more than 35
- patients of chronic pain
- drug addiction
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 |
|---|---|---|
| PENG block10ml of 0.125% isobaric bupivacaine injected | Drug | PENG Block Group |
| FICB Block20ml of 0.125% isobaric bupivacaine injected | Drug | FICB Group |
Primary outcome
Pain score using Numeric Rating scale
Time frame: 24 hours
Pain scored assessed after completion of surgery at one, six, eighteen and twenty fours
1 secondary outcome
Total Tramadol consumption
Time frame: 24 hours
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 12 Feb 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.
Moazzam Ali principal investigator
Pain Medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PENG block and FICB Block in people with Post-operative Pain Management and Hip Fracture Surgery, run by Pain Medicine Department at 1 site in Pakistan.
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 1 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 12 Feb 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain score using Numeric Rating scale (time frame: 24 hours). 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 12 Feb 2025.