Pain, PostoperativeNCT04715880
The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.
A study testing Paravertebral block/Intercostal Block (PVB/ICB) group and Paravertebral Block (PVB) group in people with Pain, Postoperative and Nerve Block, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Thoracotomy is a surgical procedure associated with severe post operative pain during the first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction and delayed return to normal activities along with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Nerve Block, Thoracotomy
- What is being tested?
- Paravertebral block/Intercostal Block (PVB/ICB) group and Paravertebral Block (PVB) group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2021to 5 Apr 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy
- Either sex
Who cannot join
- Neurological or psychiatric diseases
- Emergency Procedures.
- Language barrier
- Patients under chronic treatment with opioids
- Patients with hypersensitivity to bupivacaine
- Coagulation disorders.
- Unwilling to participate.
- Patient previously involved in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults: A Randomized Controlled Trail
Thoracotomy is a surgical procedure associated with severe post operative pain during the first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction and delayed return to normal activities along with increased morbidity and mortality. Investigators intend to compare the efficacy of two analgesic interventions (continuous infusion of paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose) on postoperative thoracotomy pain. The results of this study will direct the investigators to find the best practice methods which will reduce the postoperative thoracotomy pain, the overall cost of pain management and length of patient's hospital stay.
Read the detailed description
Objective To compare the safety, efficacy for pain relief and hemodynamic changes of two analgesic interventions(continuous infusion of Paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose)
- Conditions
- Pain, Postoperative, Nerve Block, Thoracotomy
- Being tested
- Paravertebral block/Intercostal Block (PVB/ICB) group, Paravertebral Block (PVB) group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block/Intercostal Block (PVB/ICB) groupProcedure or surgery
A paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space.
Paravertebral Block (PVB) groupProcedure or surgery
A paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block (PVB) group | Active comparator | Under complete aseptic precaution, Patient will be in lateral decubitus position a paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity.
The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour Receives: Procedure: Paravertebral Block (PVB) group |
| Paravertebral block/Intercostal Block (PVB/ICB) group | Active comparator | Under complete aseptic precaution, patient will be in lateral decubitus position a paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space. Receives: Procedure: Paravertebral block/Intercostal Block (PVB/ICB) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Visual Analogue Scale (VAS) pain Score in cm (0cm = No pain and 10 cm= Worst pain possible)
Measured: 24 hours
Blood Pressure
Blood pressure in mmHg
Measured: 24 hours
Heart Rate
Heart rate per minute
Measured: 24 Hours
Secondary outcomes (2)
Total postoperative narcotic consumption
Patient controlled intravenous analgesia (PCIA) nalbuphine or Tramadol consumption in mg
Measured: 24 hours
Sedation score
Ramsay sedation scale: 1= anxious or restless, or both, 2 = Co-operative, oriented, and tranquil, 3 = Responding to commands, 4 = brisk response to stimulus, 5 = sluggish response to stimulus, 6 = no response to stimulus
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 posted20 Jan 2021
- Study start15 Feb 2021
- Primary completion1 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kumar Sundeep, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715880
- Sponsor's protocol ID
- 2020-0797-7328
- Status last verified
- May 2021
- First submitted
- 15 Jan 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541.
PubMed 7577277Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642Kumar S, Hameed M, Shehzad R, Samad K. The comparison of the analgesic efficacy of continuous paravertebral block alone compared with continuous paravertebral and intercostal nerve block for thoracotomy in adults: a randomized controlled trial. J Anesth. 2023 Dec;37(6):923-929. doi: 10.1007/s00540-023-03255-8. Epub 2023 Sep 25.
PubMed 37747499
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT04715880
- Acronym / sponsor ID
- 2020-0797-7328
- Conditions
- Pain, Postoperative, Nerve Block, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 20 Jan 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.
Thoracotomy is a surgical procedure associated with severe post operative pain during the first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction and delayed return to normal activities along with increased morbidity and mortality. Investigators intend to compare the efficacy of two analgesic interventions (continuous infusion of paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose) on postoperative thoracotomy pain. The results of this study will direct the investigators to find the best practice methods which will reduce the postoperative thoracotomy pain, the overall cost of pain management and length of patient's hospital stay.
Detailed description
Objective To compare the safety, efficacy for pain relief and hemodynamic changes of two analgesic interventions(continuous infusion of Paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block (PVB) group | Active comparator | Procedure: Paravertebral Block (PVB) groupUnder complete aseptic precaution, Patient will be in lateral decubitus position a paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour |
| Paravertebral block/Intercostal Block (PVB/ICB) group | Active comparator | Procedure: Paravertebral block/Intercostal Block (PVB/ICB) groupUnder complete aseptic precaution, patient will be in lateral decubitus position a paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy
- Either sex
Key exclusion criteria (8 listed)
- Neurological or psychiatric diseases
- Emergency Procedures.
- Language barrier
- Patients under chronic treatment with opioids
- Patients with hypersensitivity to bupivacaine
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 |
|---|---|---|
| Paravertebral block/Intercostal Block (PVB/ICB) groupA paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space. | Procedure or surgery | Paravertebral block/Intercostal Block (PVB/ICB) group |
| Paravertebral Block (PVB) groupA paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour | Procedure or surgery | Paravertebral Block (PVB) group |
Primary outcome
Pain Score
Time frame: 24 hours
Visual Analogue Scale (VAS) pain Score in cm (0cm = No pain and 10 cm= Worst pain possible)
Blood Pressure
Time frame: 24 hours
Blood pressure in mmHg
Heart Rate
Time frame: 24 Hours
Heart rate per minute
2 secondary outcomes
Total postoperative narcotic consumption
Time frame: 24 hours
Sedation score
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 2 Jun 2021.
- Background: PubMed 7577277Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541.
- Background: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
- Derived from this study: PubMed 37747499Kumar S, Hameed M, Shehzad R, Samad K. The comparison of the analgesic efficacy of continuous paravertebral block alone compared with continuous paravertebral and intercostal nerve block for thoracotomy in adults: a randomized controlled trial. J Anesth. 2023 Dec;37(6):923-929. doi: 10.1007/s00540-023-03255-8. Epub 2023 Sep 25.
- 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.
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?
A study testing Paravertebral block/Intercostal Block (PVB/ICB) group and Paravertebral Block (PVB) group in people with Pain, Postoperative and Nerve Block, run by Aga Khan University Hospital, Pakistan 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 2 inclusion and 8 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 2 Jun 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.
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 (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715880, which also lists 3 linked publications.
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 2 Jun 2021.