Post Operative Pain, AcuteNCT06721000
Patient Control Epidural Versus Conventional Epidural.
An observational study of Post Operative Pain, Acute and Sedation Score, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion. We are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post Operative Pain, Acute, Sedation Score, Degree of Motor Block
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2023to 25 Jan 2025
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population will be from liaquat national hospital.
Who may be able to join
- Age >18 years. ASA 1-2 on pre anesthesia evaluation. Spontaneous breathing. Spo2 >95% Informed consent for participation.
Who cannot join
- A history of long-term opioid therapy (use of opioid analgesic at doses higher than codeine 120mg/day, hydrocodone 40mg/day, tramadol 200mg/day or oxycodone 40mg/day 0-4 days before surgery).
- Indication of revision surgery during immediate post operative care. Acute skin disease. Patients' refusal. ASA 3 and 4. Hypersensitivity 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.
About this study
Official title: Patient Control Epidural Versus Conventional Epidural After Total Hip Replacement
As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion.
We are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction.
Read the detailed description
More than 20 years of successful usage of epidural analgesia for post operative pain treatment include intermittent provider-administer bolus, patient control analgesia and continuous epidural infusion with or without patient control epidural analgesia. The main drawback of conventional epidural infusion is that it does not allow for individual variation in management of pain. As a result, patient control epidural analgesia has replaced it in recent years.3. It has been demonstrated that continuous epidural infusion with patient control epidural analgesia is highly effective at providing consistent analgesia, improving patient satisfaction, and reducing the workload of anesthesia provider but it is linked to higher local anesthetic consumption4 In patient undergoing THR, patient control epidural analgesia may be considered as an appropriate alternative for managing post operative pain.
- Conditions
- Post Operative Pain, Acute, Sedation Score, Degree of Motor Block, Length of Hospital Stay, Amount of Analgesic Used
- Keywords
- Patient control epidural analgesia, Conventional epidural
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCEA group | Epidural catheter is inserted and patient is given a remote to control the amount of drug given through patient control epidural pump. | |
| Non-PCEA group | Epidural catheter is inserted and the amount of drug set will be delivered via infusion pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
Patient satisfaction will be assessed after 2hours, 12hours and 24hours after surgery according to patient's pain intensity.
Score will be from 1-10, 10 means maximum satisfaction and 1 means minimal satisfaction.
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 posted6 Dec 2024
- Study start10 Nov 2023
- Primary completion30 May 2024
- Study completion25 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uruba Shamshad, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721000
- Sponsor's protocol ID
- App # 0881- 2023- LNH - ERC
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Considering patient's status of understanding i will decide it later.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Control Epidural Versus Conventional Epidural After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT06721000
- Acronym / sponsor ID
- App # 0881- 2023- LNH - ERC
- Conditions
- Post Operative Pain, Acute, Sedation Score, Degree of Motor Block, Length of Hospital Stay, Amount of Analgesic Used
- Keywords
- Patient control epidural analgesia, Conventional epidural
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 25 Jan 2025 (estimated)
- First posted
- 6 Dec 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.
As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion.
We are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction.
Detailed description
More than 20 years of successful usage of epidural analgesia for post operative pain treatment include intermittent provider-administer bolus, patient control analgesia and continuous epidural infusion with or without patient control epidural analgesia. The main drawback of conventional epidural infusion is that it does not allow for individual variation in management of pain. As a result, patient control epidural analgesia has replaced it in recent years.3. It has been demonstrated that continuous epidural infusion with patient control epidural analgesia is highly effective at providing consistent analgesia, improving patient satisfaction, and reducing the workload of anesthesia provider but it is linked to higher local anesthetic consumption4 In patient undergoing THR, patient control epidural analgesia may be considered as an appropriate alternative for managing post operative pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCEA group | – | –Epidural catheter is inserted and patient is given a remote to control the amount of drug given through patient control epidural pump. |
| Non-PCEA group | – | –Epidural catheter is inserted and the amount of drug set will be delivered via infusion pump. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population will be from liaquat national hospital.
Key inclusion criteria (1 listed)
- Age >18 years. ASA 1-2 on pre anesthesia evaluation. Spontaneous breathing. Spo2 >95% Informed consent for participation.
Key exclusion criteria (2 listed)
- A history of long-term opioid therapy (use of opioid analgesic at doses higher than codeine 120mg/day, hydrocodone 40mg/day, tramadol 200mg/day or oxycodone 40mg/day 0-4 days before surgery).
- Indication of revision surgery during immediate post operative care. Acute skin disease. Patients' refusal. ASA 3 and 4. Hypersensitivity 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.
Primary outcome
Visual analogue score
Time frame: 24 hours
Patient satisfaction will be assessed after 2hours, 12hours and 24hours after surgery according to patient's pain intensity. Score will be from 1-10, 10 means maximum satisfaction and 1 means minimal satisfaction.
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 30 Dec 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Considering patient's status of understanding i will decide it later.
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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.
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?
An observational study of Post Operative Pain, Acute and Sedation Score, run by Liaquat National Hospital & Medical College 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 2 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: enrolling by invitation, as of the sponsor's last update on 30 Dec 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 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.
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?
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?
Visual analogue score (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 30 Dec 2024.