NCT06527976

Brief Summary

Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2022

Typical duration 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

Study Start

First participant enrolled

February 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

July 26, 2024

Last Update Submit

July 26, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale score

    scale of 11 points. zero=no pain, 10 = worest pain ever

    24 hours postoperative

Secondary Outcomes (2)

  • analgesia duration

    24 hours postoperative

  • opioid consumption

    24 hours postoperative

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

dexamethasone

ACTIVE COMPARATOR
Drug: Dexamethasone

Interventions

DexmedetomidineDRUG

dexmedetomedine added to bupivacaine for adductor canal block

dexmedetomidine
DexamethasoneDRUG

dexamethasone added to bupivacaine for adductor canal block

dexamethasone

Eligibility Criteria

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

You may qualify if:

  • elective operation
  • ASA STATUS I and II

You may not qualify if:

  • patient refusal
  • ASA status III and IV
  • contraindications to local anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-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
Asisstant professor of anesthesia

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 30, 2024

Study Start

February 15, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

EG(1)