PainPhase 2NCT01454609
Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
A Phase 2 study testing 0.9% Normal saline, Bupivacaine and Bupivacaine with clonidine (combination) in people with Pain and Postoperative, run by Jawaharlal Institute of Postgraduate Medical Education & Research at 1 site in India.
Trial summary
With thyroid surgery being performed as an ambulatory procedure, most recent studies concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus block. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 0.9% Normal saline, Bupivacaine and Bupivacaine with clonidine (combination)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 2
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting consecutive euthyroid patients undergoing elective thyroidectomy under general anesthesia, of either genders and more than 18 years of age, belonging to the ASA class I and II.
Who cannot join
- Patients unable to understand visual analog pain score (VAS) or unable to use patient controlled analgesia (PCA).
- Patients with malignancy requiring block dissection or with substernal goiters - Contraindications to superficial cervical plexus block like allergy to local anesthetics, bleeding diatheses and local infection or sepsis.
- Contraindications to morphine like bronchial asthma and hypothyroidism.
- Sensitivity to the anesthetic agent used or intolerance to the medications used in the study.
- Patients who received steroids or opioids or other analgesics recently.
- Patients with history of stridor.
Trial locations and contacts
1 site in 1 country.
India1 site
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Puducherry, 605013
About this study
Official title: Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial
With thyroid surgery being performed as an ambulatory procedure, most recent studies concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine in thyroidectomy, as preemptive analgesia.
The hypothesis was bupivacaine with the addition of clonidine would help in reducing postoperative pain and thereby reduce the need for postoperative analgesia.
Read the detailed description
To find out if addition of BSCPB to general anesthesia with bupivacaine with or without clonidine prolongs the time needed for postoperative analgesic and facilitate to perform thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea and vomiting.
- Conditions
- Pain, Postoperative
- Being tested
- 0.9% Normal saline, Bupivacaine, Bupivacaine with clonidine (combination)
- Keywords
- cervical plexus block, thyroidectomy, postoperative analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Normal salineDrug
Also called Saline
Saline
BupivacaineDrug
Also called Marcaine, Sensoricaine
Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
Bupivacaine with clonidine (combination)Device
Also called Marcaine (for bupivacaine), Sensoricaine (for bupivacaine)
Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
Clonidine - 0.5 - 1 microgram/ kg
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | 0.9% normal saline Receives: Drug: 0.9% Normal saline |
| Bupivacaine | Experimental | 0.25% bupivacaine Receives: Drug: Bupivacaine |
| Bupivacaine with clonidine | Experimental | 0.25% bupivacaine with 1 microgram/kg of clonidine Receives: Device: Bupivacaine with clonidine (combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
Measured: Intraoperative to 24 hours postoperative
Secondary outcomes (3)
Visual analog pain scores at specific time intervals
Measured: 24 hours postoperative
Postoperative nausea and vomiting (PONV)and anti emetic requirements
Measured: 24 hours postoperative
Side effects of the block, morphine and clonidine
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
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 2
- 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
- Jawaharlal Institute of Postgraduate Medical Education & Research
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Karthikeyan V S, Jawaharlal Institute of Postgraduate Medical Education & Research
- Investigators
- Sarath Chandra Sistla, MS(Surgery), Study chair, Professor, Dept. of Surgery, JIPMER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454609
- Sponsor's protocol ID
- 100745483-1910201028464726
- Status last verified
- Oct 2011
- First submitted
- 8 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01454609
- Acronym / sponsor ID
- 100745483-1910201028464726
- Conditions
- Pain, Postoperative
- Keywords
- cervical plexus block, thyroidectomy, postoperative analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jawaharlal Institute of Postgraduate Medical Education & ResearchOther government
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Oct 2011 (estimated)
- 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.
With thyroid surgery being performed as an ambulatory procedure, most recent studies concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine in thyroidectomy, as preemptive analgesia.
The hypothesis was bupivacaine with the addition of clonidine would help in reducing postoperative pain and thereby reduce the need for postoperative analgesia.
Detailed description
To find out if addition of BSCPB to general anesthesia with bupivacaine with or without clonidine prolongs the time needed for postoperative analgesic and facilitate to perform thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: 0.9% Normal saline0.9% normal saline |
| Bupivacaine | Experimental | Drug: Bupivacaine0.25% bupivacaine |
| Bupivacaine with clonidine | Experimental | Device: Bupivacaine with clonidine (combination)0.25% bupivacaine with 1 microgram/kg of clonidine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting consecutive euthyroid patients undergoing elective thyroidectomy under general anesthesia, of either genders and more than 18 years of age, belonging to the ASA class I and II.
Key exclusion criteria (6 listed)
- Patients unable to understand visual analog pain score (VAS) or unable to use patient controlled analgesia (PCA).
- Patients with malignancy requiring block dissection or with substernal goiters - Contraindications to superficial cervical plexus block like allergy to local anesthetics, bleeding diatheses and local infection or sepsis.
- Contraindications to morphine like bronchial asthma and hypothyroidism.
- Sensitivity to the anesthetic agent used or intolerance to the medications used in the study.
- Patients who received steroids or opioids or other analgesics recently.
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 |
|---|---|---|
| 0.9% Normal salineAlso: SalineSaline | Drug | Saline |
| BupivacaineAlso: Marcaine, SensoricaineBupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours | Drug | Bupivacaine |
| Bupivacaine with clonidine (combination)Also: Marcaine (for bupivacaine), Sensoricaine (for bupivacaine)Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours Clonidine - 0.5 - 1 microgram/ kg | Device | Bupivacaine with clonidine |
Primary outcome
Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
Time frame: Intraoperative to 24 hours postoperative
3 secondary outcomes
Visual analog pain scores at specific time intervals
Time frame: 24 hours postoperative
Postoperative nausea and vomiting (PONV)and anti emetic requirements
Time frame: 24 hours postoperative
Side effects of the block, morphine and clonidine
Time frame: 24 hours postoperative
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 19 Oct 2011.
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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.
Sarath Chandra Sistla, MS(Surgery) study chair
Professor, Dept. of Surgery, JIPMER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.9% Normal saline, Bupivacaine and Bupivacaine with clonidine (combination) in people with Pain and Postoperative, run by Jawaharlal Institute of Postgraduate Medical Education & Research 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 6 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 19 Oct 2011. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period (time frame: Intraoperative to 24 hours postoperative). 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 19 Oct 2011.