Clinical trial NCT06214169: Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine
Official title: Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine for Intravenous Regional Anesthesia, a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Cisatracurium
Intravenous Regional Anesthesia
Lignocaine
Lead sponsor: Watim Medical & Dental College
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to onset of Sensory blockade.
timeFrame: 1-5 min.
measure: Time to onset of Motor Blockade
timeFrame: 2-7 min.
measure: Intraoperative Pain Scoring
timeFrame: 5-45 min.
measure: Regression of sensory blockade
timeFrame: 2-10 min post deflation.
measure: Regression of motor blockade
timeFrame: 2-10 min post deflation
measure: Postop Pain scoring
timeFrame: 5 minutes post deflaton till 8 hours post deflation.
measure: Time to first analgesic request post operatively.
timeFrame: 1 hour - 8 hours post deflation.
measure: Side Effects
timeFrame: From onset of blockade to 8 hours post operatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Combined Millitary Hospital
state: Punjab
Study officials:
References:
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.
citation: 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.
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.