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

NCT04130178 | Completed

• 1 other identifier: 4/10/2019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Change in pain

  by visual analogue sclae

  0 time after 2 weeks and after 2 months

• Change in the degree of inflammation

  Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

  at 0 time after 2 weeks and after 2 months

Study Arms (2)

Bupivacine injected

ACTIVE COMPARATOR

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.

Drug: Nerve block

Control group

PLACEBO COMPARATOR

Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint.

Drug: Saline injection

Interventions

Nerve block DRUG

block of the digital nerves in rheumatoid arthritis patient

Bupivacine injected

Saline injection DRUG

subcutaneous saline injection

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, 82749, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Nerve Block; Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmed Elsaman, PhD

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 17, 2019
• Study Start: October 15, 2019
• Primary Completion: January 25, 2020
• Study Completion: January 25, 2020
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

EG (1)