NCT04892420

Brief Summary

Adult patients undergoing anterior cruciate ligament repair under Spinal Anaesthesia will be randomly assigned into one of the following groups (The Four study groups will receive the standard treatment in the form of spinal anesthesia and adductor canal block), using computer generated codes and opaque sealed envelopes:

  1. 1.Group DX(DEXAMETHASONE): The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anaetthesia.
  2. 2.Group DM (dexmedetomidine)The patients receive 20 ml plain bupivacaine(0.5)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anaetthesia.
  3. 3.Group M (magnesium sulphate):The patients receive 20 ml plain bupivacaine(0.5)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anaetthesia.
  4. 4.Group C(CONTROL): The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anaetthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

May 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

May 11, 2021

Last Update Submit

January 23, 2022

Conditions

Anesthesia

Keywords

dexamethasone,magnesium sulphatedexmedetomidineadductor canal blockanterior cruciate ligament repair

Outcome Measures

Primary Outcomes (1)

  • rescue analgesia time

    time to first analgesic requirement

    first 24 hours postoperatively

Secondary Outcomes (1)

  • rescue analgesia

    24 hours

Study Arms (4)

Group DX

ACTIVE COMPARATOR

The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia

Drug: Dexamethasone

Group DM

ACTIVE COMPARATOR

The patients receive 20 ml plain bupivacaine(0.5%)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anesthesia .

Drug: Dexmedetomidine

Group M

ACTIVE COMPARATOR

The patients receive 20 ml plain bupivacaine(0.5%)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anesthesia.

Drug: Magnesium sulfate

Group C

PLACEBO COMPARATOR

The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.

Drug: Bupivacain

Interventions

DexamethasoneDRUG

The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia.

Also known as: decadrone
Group DX
DexmedetomidineDRUG

The patients receive 20 ml plain bupivacaine(0.5)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anesthesia .

Also known as: precedex
Group DM
Magnesium sulfateDRUG

The patients receive 20 ml plain bupivacaine(0.5)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anesthesia.

Also known as: english salt
Group M
BupivacainDRUG

The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.

Also known as: marcain
Group C

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years.
  • Sex: Both sexes.
  • Height 155-170 cm.
  • American Society of Anaesthesiologists (ASA) Physical Status Class-I and II.
  • Scheduled for anterior cruciate ligament under spinal anaesthesia.

You may not qualify if:

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ismail Mohammed Ibrahim

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

DexamethasoneDexmedetomidineMagnesium SulfateBupivacaine

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
using computer generated codes and opaque sealed envelopes:
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 19, 2021

Study Start

June 9, 2021

Primary Completion

August 20, 2021

Study Completion

October 30, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)