NCT05624957

Brief Summary

Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid. The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2022

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

November 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

November 3, 2022

Last Update Submit

October 18, 2023

Conditions

Postoperative PainAnalgesia

Keywords

Postoperative painLidocaineShoulder arthroscopy

Outcome Measures

Primary Outcomes (1)

  • total analgesic consumption

    total nalbuphine consumed one day after surgery

    24 hours

Secondary Outcomes (2)

  • first analgesic request

    24 hours

  • Visual analogue pain score

    24 hours

Study Arms (2)

lidocaine

EXPERIMENTAL

The patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation.

Drug: Lidocaine epinephrine

control group

PLACEBO COMPARATOR

The patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only.

Drug: Epinephrin

Interventions

Lidocaine epinephrineDRUG

Under aseptic condition every one litre of fluid irrigation will be mixture with 10 ml of lidocaine 2% and 0.25mg epinephrine and the last one use before end of surgery dexamethasone 8 mg will be added.

lidocaine
EpinephrinDRUG

0.25 mg epinephrine mixed with one litre of fluid irrigation

control group

Eligibility Criteria

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

You may qualify if:

  • Age 20-60
  • Both genders
  • Shoulder arthroscopy
  • ASA I-III

You may not qualify if:

  • Drug allergy
  • Psychiatric disorder
  • Opioid dependence
  • Liver disease
  • Patient refuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • hassan m. hetta, lecturer

    Minia University, faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 22, 2022

Study Start

November 25, 2022

Primary Completion

May 1, 2023

Study Completion

August 1, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)