Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine

NCT06214169 | Completed

• 1 other identifier: 446/23
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Randomized Control Trial is to compare the effects of addition of cisatracurium to lignocaine for IVRA Vs. Plain lignocaine in All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery (carpal tunnel, trigger finger, tendon release, fracture reduction and tendon repair). The main question\[s\] it aims to answer are: • Does addition of Cisatracurium to plain lignocaine improve the overall quality of anesthesia? • Does use of cisatracurium lead to improved postop analgesia and decreased parenteral analgesic requirements? Participants will be Forty-four patients undergoing elective hand surgery during IVRA randomly assigned to two groups of 22 patients each. All demographic details (age, gender, body weight) will be noted, all will be briefed about visual analogue score (0 to 10) for pain. Group 1 (control group) will receive lidocaine 2% diluted with saline, group 2 (cisatracurium group) will receive cisatracurium plus lidocaine 2% diluted with saline. A standard technique would be employed for IVRA. The following parameters to be assessed: onset and offset of sensory and motor block, Intra-operative pain at 5, 10, 20, 30 minutes after tourniquet application by using visual analogue score (VAS), and postoperative pain using visual analogue score (VAS) measured at 5-minute,1, 2, 4, 8 hours postoperatively.

Conditions

Anesthesia

Keywords

Cisatracurium; Intravenous Regional Anesthesia; Lignocaine

Outcome Measures

Primary Outcomes (8)

• Time to onset of Sensory blockade.

  Sensory block will be assessed by pinprick in the dermatomal sensory distribution and time noted for complete sensory blockade.

  1-5 min.

• Time to onset of Motor Blockade

  Motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers, every 30 seconds and time to be noted till inability to flex or extend the wrist and fingers is confirmed and time noted.

  2-7 min.

• Intraoperative Pain Scoring

  The severity of intraoperative pain will be assessed using 10 point VAS (Visual Analogue Score) with 1 being no pain and 10 being the worst possible pain at 5, 10, 20, 30 minutes after tourniquet application.

  5-45 min.

• Regression of sensory blockade

  Sensory blockade regression time (the time elapsed from tourniquet deflation to recovery of complete sensation in all dermatomes, determined by pinprick test) , will be noted.

  2-10 min post deflation.

• Regression of motor blockade

  Motor block regression time (the time elapsed from tourniquet deflation until regaining of flexion and extension of wrist and fingers) will be noted.

  2-10 min post deflation

• Postop Pain scoring

  Postoperative pain will be assessed by VAS at 5 minutes after tourniquet deflation and at 1, 2, 4, 8 hours postoperatively.

  5 minutes post deflaton till 8 hours post deflation.

• Time to first analgesic request post operatively.

  The first analgesic dose requirement time will also be noted (the time elapsed from tourniquet release until first request for analgesic medication postoperatively)

  1 hour - 8 hours post deflation.

• Side Effects

  Incidence of side effects such as tinnitus, dizziness, convulsions, gastric discomfort, muscle weakness and bleeding tendency will be recorded intraoperatively as well as during recovery from blockade.

  From onset of blockade to 8 hours post operatively.

Study Arms (2)

Plain Lignocaine group

OTHER

Group of participants receiving only plain lignocaine for IVRA

Drug: Lignocaine

Cisatracurium group

OTHER

Group of participants receiving plain lignocaine and cisatracurium combined for IVRA

Drug: Cisatracurium Besylate

Interventions

Cisatracurium Besylate DRUG

Addition of cisatracurium to plain lignocaine for IVRA.

Cisatracurium group

Lignocaine DRUG

Plain Lignocaine for IVRA

Plain Lignocaine group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery

You may not qualify if:

• Patients with Raynaud disease, sickle cell anemia, or a history of allergy to any drug to be used.
• Also, patients who had bleeding tendency, on anticoagulant or antiplatelet therapy, significant cardiovascular, peripheral vascular, or neurological disease.

Sponsors & Collaborators

• Watim Medical & Dental College: lead

Study Sites (1)

Combined Millitary Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (3)

• Prabhakar A, Lambert T, Kaye RJ, Gaignard SM, Ragusa J, Wheat S, Moll V, Cornett EM, Urman RD, Kaye AD. Adjuvants in clinical regional anesthesia practice: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):415-423. doi: 10.1016/j.bpa.2019.06.001. Epub 2019 Jul 2.

  PMID: 31791560 BACKGROUND

• Esmaoglu A, Akin A, Mizrak A, Turk Y, Boyaci A. Addition of cisatracurium to lidocaine for intravenous regional anesthesia. J Clin Anesth. 2006 May;18(3):194-7. doi: 10.1016/j.jclinane.2005.08.003.

  PMID: 16731321 BACKGROUND

• Farbood A, Khademi S, Tajvidi R, Hooshangi M, Salari S, Ghani M, Tahmasebi S, Jamali H. Comparison of Intravenous Regional Anesthesia with Single-Cuff Forearm Tourniquet and Hematoma Block and Traditional Method in Patients with Distal Radius Fractures; A Randomized Clinical Trial. Bull Emerg Trauma. 2020 Apr;8(2):77-82. doi: 10.30476/BEAT.2020.46446.

  PMID: 32420391 BACKGROUND

MeSH Terms

Interventions

cisatracurium; Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: Assistant Professor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 19, 2024
• Study Start: June 15, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)