Back to resultsAnalgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.
Primary Purpose
Thyroid Goiter, Thyroid Nodule
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacain
Ketorolac
Sponsored by
About this trial
This is an interventional health services research trial for Thyroid Goiter focused on measuring ketorolac, superficial cervical plexus block, thyroidectomy
Eligibility Criteria
Inclusion Criteria:
- Patients aged 20-50 years
- ASA I-II patients
- Patients going to do thyroid surgeries under general anesthesia
Exclusion Criteria:
- 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
Sites / Locations
- Sohag University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bupivacaine
bupivacaine and ketorolac
Arm Description
Outcomes
Primary Outcome Measures
1st analgesic requirement
The first time of supplemental analgesic need postoperatively
Secondary Outcome Measures
analgesic consumption
total analgesic consumption
postoperative pain
visual analogue scale(0-10) 0=no pain and 10=severe intolerable pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05180214
Brief Title
Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.
Official Title
The Effect of Adding Ketorolac to Bupivacaine in Superficial Cervical Plexus Block in Thyroid Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2021 (Actual)
Primary Completion Date
August 19, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Goiter, Thyroid Nodule
Keywords
ketorolac, superficial cervical plexus block, thyroidectomy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Title
bupivacaine and ketorolac
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
analgesic
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
analgesia
Primary Outcome Measure Information:
Title
1st analgesic requirement
Description
The first time of supplemental analgesic need postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
analgesic consumption
Description
total analgesic consumption
Time Frame
24 hours
Title
postoperative pain
Description
visual analogue scale(0-10) 0=no pain and 10=severe intolerable pain
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 20-50 years
ASA I-II patients
Patients going to do thyroid surgeries under general anesthesia
Exclusion Criteria:
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
Facility Information:
Facility Name
Sohag University Faculty of Medicine
City
Sohag
ZIP/Postal Code
52514
Country
Egypt
12. IPD Sharing Statement
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Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.
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