NCT05833776

Brief Summary

Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. However, despite its benefits, this method has been associated to an increased incidence of urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has been employed in practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

April 5, 2023

Last Update Submit

July 8, 2023

Conditions

Post Operative Pain

Keywords

IPACK Block, spinal anesthesia, Knee arthroscopy.

Outcome Measures

Primary Outcomes (1)

  • post-operative analgesia

    post-operative pain relief

    24 hours

Study Arms (2)

group F

EXPERIMENTAL

received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)

Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)

group I

EXPERIMENTAL

group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).

Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)

Interventions

spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)PROCEDURE

group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).

group Fgroup I

Eligibility Criteria

Age25 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy

You may not qualify if:

  • Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia intensive care and pain management

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 27, 2023

Study Start

January 1, 2022

Primary Completion

February 1, 2022

Study Completion

June 1, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)