Post Operative PainPhase 3NCT05277974
Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia
A Phase 3 study testing inj bupivicain in people with Post Operative Pain, run by Sheikh Zayed Medical College at 2 sites in Pakistan.
Trial summary
Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- inj bupivicain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Feb 2022to 10 Jul 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60years ASA I-III Patients undergoing elective thoracotomies
Who cannot join
- Refusal of Patient Coagulation disorders Known Allergy to Local Anesthetics Infection at the site of injection Pregnant females Morbid Obesity(BMI>40kg/m2) Psychiatric illness Diabetic Patients.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Sheikh Zayed Medical College/Hospital Rahim Yar Khan
Rahim Yar Khan, Punjab Province, 64200
amjad siddique, FCPS, 0689230165 ext. 159, dramjadsiddique74@gmail.com
- Recruiting
Sheikh Zayed Medical College/Hospital
Rahim Yar Khan, Punjab Province, 64200
Amjad Siddique, FCPS, 0689230165 ext. 159, dramjadsiddique74@gmail.com
About this study
Official title: Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy
Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Other techniques commonly utilized include Thoracic epidural, Paravertebral block; but both are associated with significant failure rate and other complications. Ultrasound guided Erector Spinae Plane block is a new regional anesthesia technique that provides analgesia at multidermatomal levels acriss the posterior, lateral and anterior thoracic walls. The rational of my study is that it is a novel technique and studies with bupivicain alone are present but no study was found with bupivicain plus dexamethasone.
- Conditions
- Post Operative Pain
- Being tested
- inj bupivicain
- Keywords
- Erector Spinae Plane Block, Thoracotomy, Ultrasound
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inj bupivicainDrug
Also called inj bupivicain plus dexamethasone
In goup B 30ml of inj. bupivicaine only will be given in Erector Spinae Plane Block and In Group D inj Bupivicain plus inj dexamethasone will be given
| Study group | Role | What they receive |
|---|---|---|
| Group B. | Active comparator | group B will receive Inj Bupivicain only in Erector Spinae Plane Block. Receives: Drug: inj bupivicain |
| Group D | Active comparator | group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block. Receives: Drug: inj bupivicain |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores
Visual Analogue Score is utilized to assess the postoperative pain
Measured: 36 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start15 Feb 2022
- Primary completion15 Jun 2022 (estimated)
- Study completion10 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amjad Siddique, Sheikh Zayed Medical College
- Investigators
- amjad siddique, FCPS, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277974
- Sponsor's protocol ID
- ASIDDIQUE SZMC
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- 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 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy
- ClinicalTrials.gov ID
- NCT05277974
- Acronym / sponsor ID
- ASIDDIQUE SZMC
- Conditions
- Post Operative Pain
- Keywords
- Erector Spinae Plane Block, Thoracotomy, Ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 10 Jul 2022 (estimated)
- First posted
- 14 Mar 2022 (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.
Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Other techniques commonly utilized include Thoracic epidural, Paravertebral block; but both are associated with significant failure rate and other complications. Ultrasound guided Erector Spinae Plane block is a new regional anesthesia technique that provides analgesia at multidermatomal levels acriss the posterior, lateral and anterior thoracic walls. The rational of my study is that it is a novel technique and studies with bupivicain alone are present but no study was found with bupivicain plus dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B. | Active comparator | Drug: inj bupivicaingroup B will receive Inj Bupivicain only in Erector Spinae Plane Block. |
| Group D | Active comparator | Drug: inj bupivicaingroup D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-60years ASA I-III Patients undergoing elective thoracotomies
Key exclusion criteria (1 listed)
- Refusal of Patient Coagulation disorders Known Allergy to Local Anesthetics Infection at the site of injection Pregnant females Morbid Obesity(BMI>40kg/m2) Psychiatric illness Diabetic Patients.
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 |
|---|---|---|
| inj bupivicainAlso: inj bupivicain plus dexamethasoneIn goup B 30ml of inj. bupivicaine only will be given in Erector Spinae Plane Block and In Group D inj Bupivicain plus inj dexamethasone will be given | Drug | Group B., Group D |
Primary outcome
postoperative pain scores
Time frame: 36 hours postoperatively
Visual Analogue Score is utilized to assess the postoperative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- 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.
amjad siddique, FCPS principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing inj bupivicain in people with Post Operative Pain, run by Sheikh Zayed Medical College at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amjad siddique, FCPS (0689230165 ext. 159, dramjadsiddique74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain scores (time frame: 36 hours postoperatively). 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 Mar 2022.