NCT03731468

Brief Summary

studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

July 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

July 9, 2018

Last Update Submit

March 9, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative analgesia duration

    time of first analgesic requirement is the time of end of block analgesia

    24 hour postoperative

Secondary Outcomes (1)

  • postoperative complications related to the block

    8 hours

Study Arms (2)

dexmethasone group

ACTIVE COMPARATOR

8 mg dexamethasone will be added to local anaesthetics

Drug: Dexamethasone

control group

SHAM COMPARATOR

isobaric bupivacaine will be given on each side

Drug: local anesthetic

Interventions

local anestheticDRUG

ultrasound guided superficial cervical block in thyroid surgery

control group
DexamethasoneDRUG

dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery

dexmethasone group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective surgery
  • ASA 1, II, AND III

You may not qualify if:

  • Patient refusal
  • Infection at the entry site
  • BMI \> 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, LocalDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

July 9, 2018

First Posted

November 6, 2018

Study Start

September 15, 2018

Primary Completion

January 1, 2020

Study Completion

December 1, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

EG(1)