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NCT Number: NCT06214169

Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine

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.

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Key information

Conditions

Anesthesia

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Millitary Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cisatracurium Besylate

Drug

Addition of cisatracurium to plain lignocaine for IVRA.

lignocaine

Drug

Plain Lignocaine for IVRA

Primary outcomes

  1. Time to onset of Sensory blockade.

    Time frame: 1-5 min.

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

  2. Time to onset of Motor Blockade

    Time frame: 2-7 min.

    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.

  3. Intraoperative Pain Scoring

    Time frame: 5-45 min.

    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.

  4. Regression of sensory blockade

    Time frame: 2-10 min post deflation.

    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.

  5. Regression of motor blockade

    Time frame: 2-10 min post deflation

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

  6. Postop Pain scoring

    Time frame: 5 minutes post deflaton till 8 hours post deflation.

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

  7. Time to first analgesic request post operatively.

    Time frame: 1 hour - 8 hours post deflation.

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

  8. Side Effects

    Time frame: From onset of blockade to 8 hours post operatively.

    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.

Sponsors and collaborators

Lead sponsor

Watim Medical & Dental College

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2024
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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