PainPhase 4NCT04835116
Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.
A Phase 4 study testing Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. and paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. in people with Pain and Postoperative Pain, run by Armed Forces Institute of Urology, Rawalpindi at 1 site in Pakistan.
Trial summary
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative Pain
- What is being tested?
- Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. and paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Apr 2019to 11 Oct 2019
- Phase
- Phase 4
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing PCNL
- age from 12-65 years
- normal renal functions
- no history of chronic pain
- ASA I, II \& III
- Both genders
Who cannot join
- history of local anaesthesia allergy
- Redo PCNL
- Multiple punctures during PCNL
- Excessive intra-operative bleeding
- Diabetes mellitus
- Coagulopathy
Show all 9Show fewer
- Mental disorder
- ASA IV \& V
- Active urinary tract infection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Urology.
Rawalpindi, Punjab Province, 47040
About this study
Official title: Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.
Read the detailed description
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.
- Conditions
- Pain, Postoperative Pain
- Being tested
- Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg., paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
- Keywords
- Local anesthesia, Percutaneous nephrolithotomy.
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.Drug
Also called Local Anesthesia
Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.
paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.Drug
Also called Intravenous analgesic
Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthesia | Other | Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine. Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. |
| Intravenous Analgesics | Other | Group B patients received postoperative intravenous analgesia. Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL.
Measurement: Postoperative pain Measurement tool: Visual analog scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start11 Apr 2019
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Urology, Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musab Umair Khalid, Armed Forces Institute of Urology, Rawalpindi
- Investigators
- Musab Umair, MBBS, Principal investigator, Armed Forces Institute of Urology.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835116
- Sponsor's protocol ID
- AFIU Rawalpindi
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
- ClinicalTrials.gov ID
- NCT04835116
- Acronym / sponsor ID
- AFIU Rawalpindi
- Conditions
- Pain, Postoperative Pain
- Keywords
- Local anesthesia, Percutaneous nephrolithotomy.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Armed Forces Institute of Urology, RawalpindiUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 8 Apr 2021 (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.
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.
Detailed description
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthesia | Other | Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg., Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine. |
| Intravenous Analgesics | Other | Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg., Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.Group B patients received postoperative intravenous analgesia. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- all patients undergoing PCNL
- age from 12-65 years
- normal renal functions
- no history of chronic pain
- ASA I, II \& III
Key exclusion criteria (9 listed)
- history of local anaesthesia allergy
- Redo PCNL
- Multiple punctures during PCNL
- Excessive intra-operative bleeding
- Diabetes mellitus
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 Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.Also: Local AnesthesiaGroup A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly. | Drug | Intravenous Analgesics, Local Anesthesia |
| paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.Also: Intravenous analgesicGroup B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required | Drug | Intravenous Analgesics, Local Anesthesia |
Primary outcome
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Time frame: 6 months
Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL. Measurement: Postoperative pain Measurement tool: Visual analog scale
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 14 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Musab Umair, MBBS principal investigator
Armed Forces Institute of Urology.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. and paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. in people with Pain and Postoperative Pain, run by Armed Forces Institute of Urology, Rawalpindi 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 6 inclusion and 9 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 14 Apr 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy. (time frame: 6 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 14 Apr 2021.