NCT05269095

Brief Summary

This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing knee arthroscopy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

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 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

March 4, 2022

Last Update Submit

March 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24-hour rescue analgesic consumption

    Total postoperative 24-hour rescue analgesic consumption will be recorded

    24 hours postoperative

Secondary Outcomes (2)

  • Post-operative pain

    24 hours Postoperative

  • Time taken till 1st rescue analgesic request

    24 hours Postoperative

Study Arms (3)

spinal anesthesia only

EXPERIMENTAL

Patients will receive spinal anesthesia only

Procedure: Spinal anesthesia only

spinal anesthesia and ultrasound-guided Genicular nerves block

EXPERIMENTAL

Patients will receive spinal anesthesia and ultrasound-guided Genicular nerves block

Biological: Spinal anesthesia and ultrasound-guided Genicular nerves block

Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace

EXPERIMENTAL

Patients will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block plus infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (PACK) block.

Biological: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)

Interventions

Patients will receive spinal anesthesia with 2-3 ml 0.5% (10-15 mg) hyperbaric bupivacaine plus 25 ug fentanyl at the L3/4 interspaces.

spinal anesthesia only

Patients will receive16 ml bupivacaine 0025% will be administered, and4 ml of this solution will be placed at each of the 4 target nerves.

spinal anesthesia and ultrasound-guided Genicular nerves block

Adductor Canal block (ACB) technique will be performed using 16 ml bupivacaine 0025% As regarding the Popliteal artery and the capsule of posterior knee block ('PACK), it will be performed Using 16 ml bupivacaine 0.25%

Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-60 years
  • Both genders
  • American Society of Anaesthesiologists physical status classification I - III
  • Patients scheduled for elective unilateral knee arthroscopy under spinal anesthesia

You may not qualify if:

  • Patient refusal
  • Preoperative neurological deficits
  • Opioid-dependent (opioid intake more than 3 months)
  • Chronic pain conditions
  • Significant cardiac and respiratory disease
  • Pre-existing major organ dysfunction such as hepatic and renal failure
  • Coexisting hematological disorder or deranged coagulation parameters
  • Psychiatric illnesses
  • Allergy to any of the drugs used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, SpinalMethods

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 7, 2022

Study Start

March 21, 2022

Primary Completion

March 20, 2023

Study Completion

March 21, 2023

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

The data will be available under a reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL
Time Frame
One year after the end of the study