NCT05794685

Brief Summary

Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

March 2, 2023

Last Update Submit

August 16, 2024

Conditions

Keywords

ultrasound guided adductor canal block .4 in 1 block .knee surgeries .

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain score: resting and dynamic .

    Postoperative pain score: resting and dynamic pain using NRS at postoperative 6 hours.Numerical rating scales (NRSs) are the simplest and most commonly used scales. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around (written version) the number that best describes the pain dimension, usually intensity.

    6 hours Postoperative

  • Postoperative pain score: resting and dynamic

    Postoperative pain score: resting and dynamic pain using NRS at postoperative 12 hours.

    12 hours post operative

  • Postoperative pain score: resting and dynamic

    Postoperative pain score: resting and dynamic pain using NRS at postoperative 18 hours.

    18 hours post operative

  • Postoperative pain score: resting and dynamic

    Postoperative pain score: resting and dynamic pain using NRS at postoperative 24 hours.

    24 hours post operative.

Secondary Outcomes (3)

  • Change of blood pressure .

    Intraoperative

  • Change of heart rate .

    Intraoperative

  • Postoperative opioid requirements .

    24 hours post operative

Study Arms (2)

adductor canal block

ACTIVE COMPARATOR

adductor canal block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle

Procedure: adductor canal blockProcedure: 4 in one block

4 in one block

ACTIVE COMPARATOR

4 in one block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery .

Procedure: adductor canal blockProcedure: 4 in one block

Interventions

patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle (adductor canal block).

4 in one blockadductor canal block

patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery (4 in one block).

4 in one blockadductor canal block

Eligibility Criteria

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

You may qualify if:

  • Both sexes.
  • ASA grade 1 and 2.
  • Age group between 20-60 years.
  • Patients who will undergo knee surgeries under neuroaxial anesthesia.

You may not qualify if:

  • Patient refusal.
  • Patients who are allergic to any of study drugs.
  • Absolute contraindication causes to spinal anesthesia due to coagulopathy, severe aortic/mitral stenosis, or active infection at site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine.Beni-suef university

Cairo, 62511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative Randomized Study between 2 groups
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Professor of Anesthesiology and Surgical Intensive Care and pain medicine

Study Record Dates

First Submitted

March 2, 2023

First Posted

April 3, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations