NCT05180214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

December 17, 2021

Last Update Submit

January 6, 2022

Conditions

Thyroid GoiterThyroid Nodule

Keywords

ketorolac, superficial cervical plexus block, thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • 1st analgesic requirement

    The first time of supplemental analgesic need postoperatively

    24 hours

Secondary Outcomes (2)

  • analgesic consumption

    24 hours

  • postoperative pain

    24 hours

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR
Drug: Bupivacain

bupivacaine and ketorolac

ACTIVE COMPARATOR
Drug: BupivacainDrug: Ketorolac

Interventions

BupivacainDRUG

analgesic

bupivacainebupivacaine and ketorolac
KetorolacDRUG

analgesia

bupivacaine and ketorolac

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 20-50 years
  • ASA I-II patients
  • Patients going to do thyroid surgeries under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Faculty of Medicine

Sohag, 52514, Egypt

Location

MeSH Terms

Conditions

GoiterThyroid Nodule

Interventions

BupivacaineKetorolac

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lectuerer of Anesthesia and ICU

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 6, 2022

Study Start

January 17, 2021

Primary Completion

August 19, 2021

Study Completion

September 15, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

EG(1)