NCT06265441

Brief Summary

In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started May 2024

Shorter than P25 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

February 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 5, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 7, 2024

Last Update Submit

November 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure.

    Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study.

    8 hours

Secondary Outcomes (3)

  • Total pethidine consumption

    24 hours

  • The time till first analgesic requirement

    as requested by patient

  • The number of steps

    24 hours

Study Arms (2)

Group A : Adductor canal block only

EXPERIMENTAL

Patients will receive Adductor canal block under ultrasound guide of 20 ml bupivacaine 0.25%

Procedure: Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected

Group B : Adductor canal + IPACK block

ACTIVE COMPARATOR

Patients will receive Adductor canal block and IPACK block under ultrasound guidance with 20 ml bupivacaine 0.25% for each block

Procedure: Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%

Interventions

The patients in group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the patients are placed in the supine position with the arms resting comfortably across the chest and the affected lower extremity is externally rotated. Adductor canal was identified beneath the sartorius muscle and 22-gauge 90-mm spinal needle is inserted from anterolateral to posteromedial direction at a point approximately at the junction between the middle and distal third of the thigh on the anteromedial femur, this location is called mid adductor canal, then 20 ml of 0.25% bupivacaine is injected in the canal

Group A : Adductor canal block only

The patients in Group B will receive adductor canal block as described in group A then IPACK block, in which the patients are placed in a supine position and knee is placed in position of 90° flexion. A low-frequency ultrasound probe is positioned in the popliteal crease 1 finger breadth above the patella, and a spinal needle is inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle is placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine is injected while the needle is being withdrawn after negative aspiration.

Group B : Adductor canal + IPACK block

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physical status: ASA 1 or 2
  • Age group: 21-40 years.
  • No sex predilection.
  • Patients undergoing arthroscopic knee surgery under spinal anesthesia.

You may not qualify if:

  • Patient refusal
  • Physical status: ASA III or above.
  • Patients with contraindications for spinal anesthesia.
  • Patients with history of drug allergies to study drugs.
  • Evidence of local infection at site of injection.
  • Neuromuscular pathology (example: - Multiple Sclerosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mohamed Morsi, M.B.B.CH

    Anesthesia resident, Ain shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 20, 2024

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

November 5, 2024

Record last verified: 2024-02

Locations