Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine

Anesthesia Clinical Trial

Official title:

Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine for Intravenous Regional Anesthesia, a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06214169
• Other study ID #: 446/23
• Status: Completed
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: Watim Medical & Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Cisatracurium Besylate
Addition of cisatracurium to plain lignocaine for IVRA.
• Lignocaine
Plain Lignocaine for IVRA

Locations

Country	Name	City	State
Pakistan	Combined Millitary Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Watim Medical & Dental College

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Erratum In: Best Pract Res Clin Anaesthesiol. 2021 Dec;35(4):E3-E4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.