Thyroid GoiterPhase 2NCT05180214
Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.
A Phase 2 study testing Bupivacain and Ketorolac in people with Thyroid Goiter and Thyroid Nodule, run by Sohag University at 1 site in Egypt.
Trial summary
Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Thyroid Goiter, Thyroid Nodule
- What is being tested?
- Bupivacain and Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2021to 15 Sep 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 20-50 years
- ASA I-II patients
- Patients going to do thyroid surgeries under general anesthesia
Who cannot join
- Patient refusal
- Known history of sensitivity to the drug used in the study
- Drug abuse
- Infection at the site of the block
- Presence of coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding Ketorolac to Bupivacaine in Superficial Cervical Plexus Block in Thyroid Surgery.
Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.
- Conditions
- Thyroid Goiter, Thyroid Nodule
- Being tested
- Bupivacain, Ketorolac
- Keywords
- ketorolac, superficial cervical plexus block, thyroidectomy
- Medical subject headings
- Goiter, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
analgesic
KetorolacDrug
analgesia
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | Not described Receives: Drug: Bupivacain |
| bupivacaine and ketorolac | Active comparator | Not described Receives: Drug: Bupivacain; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st analgesic requirement
The first time of supplemental analgesic need postoperatively
Measured: 24 hours
Secondary outcomes (2)
analgesic consumption
total analgesic consumption
Measured: 24 hours
postoperative pain
visual analogue scale(0-10) 0=no pain and 10=severe intolerable pain
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 posted6 Jan 2022
- Study start17 Jan 2021
- Primary completion19 Aug 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid GoiterStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad Soliman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180214
- Sponsor's protocol ID
- 2006
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Ketorolac to Bupivacaine in Superficial Cervical Plexus Block in Thyroid Surgery.
- ClinicalTrials.gov ID
- NCT05180214
- Acronym / sponsor ID
- 2006
- Conditions
- Thyroid Goiter, Thyroid Nodule
- Keywords
- ketorolac, superficial cervical plexus block, thyroidectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 6 Jan 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.
Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: Bupivacain |
| bupivacaine and ketorolac | Active comparator | Drug: Bupivacain, Drug: Ketorolac |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 20-50 years
- ASA I-II patients
- Patients going to do thyroid surgeries under general anesthesia
Key exclusion criteria (5 listed)
- Patient refusal
- Known history of sensitivity to the drug used in the study
- Drug abuse
- Infection at the site of the block
- Presence of coagulopathy
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 |
|---|---|---|
| Bupivacainanalgesic | Drug | bupivacaine, bupivacaine and ketorolac |
| Ketorolacanalgesia | Drug | bupivacaine and ketorolac |
Primary outcome
1st analgesic requirement
Time frame: 24 hours
The first time of supplemental analgesic need postoperatively
2 secondary outcomes
analgesic consumption
Time frame: 24 hours
postoperative pain
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 21 Jan 2022.
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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 Phase 2 study testing Bupivacain and Ketorolac in people with Thyroid Goiter and Thyroid Nodule, run by Sohag University at 1 site in Egypt.
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 3 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 21 Jan 2022. 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 Egypt. 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 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?
1st analgesic requirement (time frame: 24 hours). 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 21 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.