NCT07090928

Brief Summary

The investigator's aim is to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing post-operative pain compared to placebo in patients undergoing knee arthroscopic procedures.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_4

Status
not yet recruiting

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

July 4, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 29, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

July 4, 2025

Last Update Submit

July 24, 2025

Conditions

Arthroscopic Surgery

Keywords

BupivacainePostoperative PainPort Site PainArthroscopyMobility ImprovementLocal AnestheticPerioperative AnalgesiaMinimally Invasive SurgeryRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Postoperative Port Site Pain Score

    Pain will be measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain), at the port site following knee arthroscopy.

    6 hours, 12 hours, and 24 hours postoperatively

Secondary Outcomes (1)

  • Proportion of Patients Achieving Early Mobility

    Assessed after 6 hours of completion of procedure

Study Arms (2)

Intervention group

EXPERIMENTAL

group A (intervention group) will receive 5 ml of 0.5% bupivacaine infiltrated at each port site

Drug: 5 ml of 0.5% bupivacaine infiltrated at each port site

Control group

PLACEBO COMPARATOR

Group B (intervention group) will receive 5 ml of 0.9% Normal Saline infiltrated at each port site

Drug: Placebo

Interventions

5 ml of 0.5% bupivacaine infiltrated at each port siteDRUG

5 ml of 0.5% bupivacaine infiltrated at each port site after the arthroscopic procedures

Intervention group
PlaceboDRUG

5ml 0.9%normal saline infiltrated at port site

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Medical Officer

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 29, 2025

Study Start

August 1, 2025

Primary Completion

January 31, 2026

Study Completion

March 31, 2026

Last Updated

July 29, 2025

Record last verified: 2025-06