Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Saline injection; Drug: Nerve block

• Registration Number: NCT04130178
• Lead Sponsor: Sohag University

Brief Summary

Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.

PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.

Detailed Description

PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.

Study Timeline

• Study First Submitted: 2019-10-11
• Study Start: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Primary Completion: 2020-01-25
• Study Completion: 2020-01-25
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Rheumatoid arthritis patient according to ACR/EULAR criteria
• age >18
• bilateral hand affection

Exclusion Criteria

• peripheral neuropathy
• other chronic arthritis
• patient who did mastectomy or any other hand operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group	Saline injection	Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint.
Bupivacine injected	Nerve block	Half ml of Bupivicaine hydrochloride .5% (Marcaine, Pfizer) was injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP on each side of the selected joint.

Primary Outcome Measures

Name	Time	Method
Change in pain	0 time after 2 weeks and after 2 months	by visual analogue sclae
Change in the degree of inflammation	at 0 time after 2 weeks and after 2 months	Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

Trial Locations

Locations (1)

Sohag university; 🇪🇬 Sohag, Egypt