Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative AnalgesiaPhase 4NCT03667352
Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties
A Phase 4 study testing Unilateral Scalp Block, Transversus abdominis plane block and Intravenous Fentanyl in people with Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia, run by Dhritiman Chakrabarti at 1 site in India.
Trial summary
This study assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (TAP) block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties (ABFC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia
- What is being tested?
- Unilateral Scalp Block, Transversus abdominis plane block and Intravenous Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jul 2017to 15 May 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing Abdominal bone flap replacement.
Who cannot join
- Motor and comprehensive aphasia,
- Disoriented mental state or Inability to follow commands.
- Hypersensitivity to amide local anesthetics,
- Bone flap site infection
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties: A Prospective, Randomised, Double Blind Study
This study assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (TAP) block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties (ABFC).
Read the detailed description
Scalp blocks with local anaesthetic agents along with general anaesthesia provides intraoperative and postoperative analgesia by blunting the hemodynamic responses to noxious stimuli. The transversus abdominis plane "TAP" block, a regional anaesthesia technique that provides analgesia following abdominal surgery. It involves a single large bolus injection of local anaesthetic into an anatomical space between the internal oblique and transversus abdominis muscles.
Ropivacaine is less cardio toxic, less arrhythmogenic, less toxic to central nervous system (CNS) than bupivacaine, and it also has intrinsic vasoconstrictor property. Clonidine is an alpha-2 receptor agonist, which has a known property of reducing requirement of analgesics in the perioperative period.
This study aimed to assess the efficacy of scalp block and TAP block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties.
- Being tested
- Unilateral Scalp Block, Transversus abdominis plane block, Intravenous Fentanyl
- Keywords
- Scalp block, Transversus abdominis plane block, Ropivacaine, Clonidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Scalp BlockProcedure or surgery
Scalp block is provided by injecting local anaesthetic in the scalp at specific areas to block 6 nerves which are responsible for sensory innervation of the scalp - Supraorbital and supratrochlear nerves, Zygomaticotemporal nerve, Auriculotemporal nerve, Greater and lesser occipital nerves.
Transversus abdominis plane blockProcedure or surgery
Also called TAP block
The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). It is usually accomplished by a single bolus injection into the transversus abdominis plane through the lumbar triangle of Petit and can be accomplished either by blind landmark based technique or alternatively under ultrasound guidance (as in this study).
Intravenous FentanylDrug
Fentanyl is a commonly used opioid drug administered for analgesia in the perioperative period. It may be used as either intermittent bolus administration or continuous infusion or a combination of the two. Usual infusion doses range from 1-2 microgram/kg/hr, which may be titrated based on intraoperative haemodynamics or postoperative patient reported pain scores.
| Study group | Role | What they receive |
|---|---|---|
| Scalp & TAP Block (Group T) | Experimental | Group T received 0.2% Ropivacaine + clonidine 1µg/kg mixture, for ipsilateral scalp block (10ml),TAP block under USG guidance (20ml) and intravenous saline 0.1ml/kg/hr (sham infusion) for continuous infusion. Receives: Procedure: Unilateral Scalp Block; Procedure: Transversus abdominis plane block |
| Intravenous Fentanyl (Group C) | Active comparator | Group C received saline, for ipsilateral scalp block (10ml) and TAP block under USG guidance (20ml) and I.V fentanyl 1 µg/kg/hr as analgesic. Receives: Drug: Intravenous Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Postoperative Rescue Analgesia requirement between groups
Postoperative rescue analgesia (Inj. paracetamol 1gm I.V) if patient reported pain measured by visual analogue score was ≥ 4.
Visual analogue scale (VAS) is a self reported score for estimation of pain which ranges between 1 (no pain) to 10 (worst possible pain).
VAS score interpretation: No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10.
Measured: Measured at 1, 6 and 24 hours postoperatively.
Secondary outcomes (4)
Difference in intraoperative trend of Heart rate between groups
Heart rate measured intraoperatively will be compared between the groups.
Measured: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Difference in intraoperative trend of Systolic blood pressure between groups
Systolic blood pressure measured intraoperatively will be compared between the groups.
Measured: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Difference in intraoperative trend of Diastolic blood pressure between groups
Diastolic blood pressure measured intraoperatively will be compared between the groups.
Measured: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Difference in patient reported postoperative pain
Postoperative pain measured by measured by visual analogue scoring system (VAS).
Range: 1-10. No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10.
Measured: Measured at 1, 6 and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start15 Jul 2017
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative AnalgesiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhritiman Chakrabarti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667352
- Sponsor's protocol ID
- DNBT-61/2017
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties: A Prospective, Randomised, Double Blind Study
- ClinicalTrials.gov ID
- NCT03667352
- Acronym / sponsor ID
- DNBT-61/2017
- Keywords
- Scalp block, Transversus abdominis plane block, Ropivacaine, Clonidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dhritiman ChakrabartiUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 12 Sep 2018 (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 assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (TAP) block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties (ABFC).
Detailed description
Scalp blocks with local anaesthetic agents along with general anaesthesia provides intraoperative and postoperative analgesia by blunting the hemodynamic responses to noxious stimuli. The transversus abdominis plane "TAP" block, a regional anaesthesia technique that provides analgesia following abdominal surgery. It involves a single large bolus injection of local anaesthetic into an anatomical space between the internal oblique and transversus abdominis muscles.
Ropivacaine is less cardio toxic, less arrhythmogenic, less toxic to central nervous system (CNS) than bupivacaine, and it also has intrinsic vasoconstrictor property. Clonidine is an alpha-2 receptor agonist, which has a known property of reducing requirement of analgesics in the perioperative period.
This study aimed to assess the efficacy of scalp block and TAP block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalp & TAP Block (Group T) | Experimental | Procedure: Unilateral Scalp Block, Procedure: Transversus abdominis plane blockGroup T received 0.2% Ropivacaine + clonidine 1µg/kg mixture, for ipsilateral scalp block (10ml),TAP block under USG guidance (20ml) and intravenous saline 0.1ml/kg/hr (sham infusion) for continuous infusion. |
| Intravenous Fentanyl (Group C) | Active comparator | Drug: Intravenous FentanylGroup C received saline, for ipsilateral scalp block (10ml) and TAP block under USG guidance (20ml) and I.V fentanyl 1 µg/kg/hr as analgesic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Abdominal bone flap replacement.
Key exclusion criteria (5 listed)
- Motor and comprehensive aphasia,
- Disoriented mental state or Inability to follow commands.
- Hypersensitivity to amide local anesthetics,
- Bone flap site infection
- Coagulation disorders
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 |
|---|---|---|
| Unilateral Scalp BlockScalp block is provided by injecting local anaesthetic in the scalp at specific areas to block 6 nerves which are responsible for sensory innervation of the scalp - Supraorbital and supratrochlear nerves, Zygomaticotemporal nerve, Auriculotemporal nerve, Greater and lesser occipital nerves. | Procedure or surgery | Scalp & TAP Block (Group T) |
| Transversus abdominis plane blockAlso: TAP blockThe transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). It is usually accomplished by a single bolus injection into the transversus abdominis plane through the lumbar triangle of Petit and can be accomplished either by blind landmark based technique or alternatively under ultrasound guidance (as in this study). | Procedure or surgery | Scalp & TAP Block (Group T) |
| Intravenous FentanylFentanyl is a commonly used opioid drug administered for analgesia in the perioperative period. It may be used as either intermittent bolus administration or continuous infusion or a combination of the two. Usual infusion doses range from 1-2 microgram/kg/hr, which may be titrated based on intraoperative haemodynamics or postoperative patient reported pain scores. | Drug | Intravenous Fentanyl (Group C) |
Primary outcome
Difference in Postoperative Rescue Analgesia requirement between groups
Time frame: Measured at 1, 6 and 24 hours postoperatively.
Postoperative rescue analgesia (Inj. paracetamol 1gm I.V) if patient reported pain measured by visual analogue score was ≥ 4. Visual analogue scale (VAS) is a self reported score for estimation of pain which ranges between 1 (no pain) to 10 (worst possible pain). VAS score interpretation: No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10.
4 secondary outcomes
Difference in intraoperative trend of Heart rate between groups
Time frame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Difference in intraoperative trend of Systolic blood pressure between groups
Time frame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Difference in intraoperative trend of Diastolic blood pressure between groups
Time frame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Difference in patient reported postoperative pain
Time frame: Measured at 1, 6 and 24 hours postoperatively.
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 Sep 2018.
- Individual participant dataSharing planned: No
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 Phase 4 study testing Unilateral Scalp Block, Transversus abdominis plane block and Intravenous Fentanyl in people with Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia, run by Dhritiman Chakrabarti at 1 site in India.
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 5 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 Sep 2018. 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 India. 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?
Difference in Postoperative Rescue Analgesia requirement between groups (time frame: Measured at 1, 6 and 24 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 Sep 2018.