Comparison Between Bupivacaine and Ropivacaine in Patients Undergoing Forearm Surgeries Under Brachial Plexus Block

NCT04729842 | Completed

• 1 other identifier: AssamMC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective comparative randomized study was done to compare Bupivacaine and Ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block. The study compares the onset and duration of sensory block, onset and duration of motor block and duration of analgesia between these two drugs.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (2)

• Onset of sensory block

  Sensory block was tested with a 22-gauge hypodermic needle by using the pinprick test and compared with the contra-lateral hand. Sensory block was graded as Grade 0: Sharp pin felt, Grade 1: Analgesia, dull sensation felt and Grade 2: Anaesthesia, no sensation felt.

  Time in minutes from the completion of injection of the study drug till the loss of pinprick sensation. The estimated time frame from injection of study drug to onset of sensory block is 15 minutes.

• Duration of sensory block

  Duration was assessed from loss of pinprick sensation to return of sensation.

  Time in minutes between onset of sensory blockade and return of dull sensation to pin prick. The estimated time frame for duration of sensory block is 540 minutes.

Secondary Outcomes (3)

• Onset of motor block

  Time from the completion of injection of the study drug till the patient is unable to move his fingers. The estimated time frame for onset of motor block is 20 minutes.

• Duration of motor block

  Time in minutes between onset of motor blockade and time at which patient could first move their fingers. The estimated time frame for duration of motor block is 480 minutes.

• Duration of analgesia

  Time in minutes between onset of sensory block and patient's first analgesic request. Time frame for duration of analgesia is 600 minutes

Study Arms (2)

Group - B , Patients who recieved Bupivacaine

ACTIVE COMPARATOR

30 ml of 0.5% bupivacaine was injected equally divided and injected in four nerves (musculocutaneous, median, radial and ulnar nerves)

Procedure: Axillary Brachial plexus block

Group - R , Patients who received Ropivacaine

ACTIVE COMPARATOR

30 ml of a solution containing 0.5% ropivacaine was equally divided and injected in the four nerves (musculocutaneous, median, radial and ulnar nerves)

Procedure: Axillary Brachial plexus block

Interventions

Axillary Brachial plexus block PROCEDURE

Brachial plexus block via axillary route was administered using 30 ml of 0.5% Bupivacaine in group B and 30 ml of 0.5% Ropivacaine in Group R

Also known as: Brachial plexus block for forearm surgeries

Group - B , Patients who recieved Bupivacaine; Group - R , Patients who received Ropivacaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients with ASA classes I and II who gave consent and were candidates for elective forearm surgeries.

You may not qualify if:

• Any allergic reactions to ropivacaine, bupivacaine and lignocaine.
• All patients with hypertension, cardiac, hepatic or renal diseases.
• Pregnant women, drug abusers and psychiatric patients.
• Patient who had an anatomical or vascular abnormality in the upper extremity.
• Bleeding diathesis.
• Local infection of the axilla.
• Patient refusal.

Sponsors & Collaborators

• Assam Medical College: lead

Related Publications (13)

• Brennan F, Lohman D, Gwyther L. Access to Pain Management as a Human Right. Am J Public Health. 2019 Jan;109(1):61-65. doi: 10.2105/AJPH.2018.304743.

  PMID: 32941757 BACKGROUND

• Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.

  PMID: 19282714 BACKGROUND

• Armstrong KP, Cherry RA. Brachial plexus anesthesia compared to general anesthesia when a block room is available. Can J Anaesth. 2004 Jan;51(1):41-4. doi: 10.1007/BF03018545.

  PMID: 14709459 BACKGROUND

• Clarkson CW, Hondeghem LM. Mechanism for bupivacaine depression of cardiac conduction: fast block of sodium channels during the action potential with slow recovery from block during diastole. Anesthesiology. 1985 Apr;62(4):396-405.

  PMID: 2580463 BACKGROUND

• Hickey R, Hoffman J, Ramamurthy S. A comparison of ropivacaine 0.5% and bupivacaine 0.5% for brachial plexus block. Anesthesiology. 1991 Apr;74(4):639-42. doi: 10.1097/00000542-199104000-00002.

  PMID: 2008942 BACKGROUND

• De Andres J, Sala-Blanch X. Peripheral nerve stimulation in the practice of brachial plexus anesthesia: a review. Reg Anesth Pain Med. 2001 Sep-Oct;26(5):478-83. doi: 10.1053/rapm.2001.26485. No abstract available.

  PMID: 11561271 BACKGROUND

• Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002 Feb 16;359(9306):614-8. doi: 10.1016/S0140-6736(02)07750-4.

  PMID: 11867132 BACKGROUND

• Cline E, Franz D, Polley RD, Maye J, Burkard J, Pellegrini J. Analgesia and effectiveness of levobupivacaine compared with ropivacaine in patients undergoing an axillary brachial plexus block. AANA J. 2004 Oct;72(5):339-45.

  PMID: 15529729 BACKGROUND

• Thornton KL, Sacks MD, Hall R, Bingham R. Comparison of 0.2% ropivacaine and 0.25% bupivacaine for axillary brachial plexus blocks in paediatric hand surgery. Paediatr Anaesth. 2003 Jun;13(5):409-12. doi: 10.1046/j.1460-9592.2003.01065.x.

  PMID: 12791114 BACKGROUND

• Kooloth RA, Patel SN, Mehta MK. A comparison of 0.5% Ropivacaine and 0.5% Bupivacaine in supraclavicular brachial plexus block -. National Journal of Medical Research. 2015;5(1):67-70.

  BACKGROUND

• Kaur A, Singh RB, Tripathi RK, Choubey S. Comparision between bupivacaine and ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block: a prospective randomized study. J Clin Diagn Res. 2015 Jan;9(1):UC01-6. doi: 10.7860/JCDR/2015/10556.5446. Epub 2015 Jan 1.

  PMID: 25738062 RESULT

• Rathod H, Parikh H, Upadhayaya RM. Comparative study of 0.375% bupivacaine and 0.375% ropivacaine in brachial plexus block via supraclavicular approach. Int Jour of Biomed Res. 2015 Feb 28;6(2):77-82.

  RESULT

• Modak S, Basantwani S. Comparative study of 0.5% ropivacaine and 0.5% bupivacaine for brachial plexus block by supraclavicular approach for upper limb surgeries. International Journal of Basic & Clinical Pharmacology. 2017 Jan 5;5(4):1205-9.

  RESULT

Related Links

• OpenEpi - Toolkit Shell for Developing New Applications \[Internet\].

MeSH Terms

Interventions

Brachial Plexus Block

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were blind to the study of drugs. Blinding was achieved by the examiner of the study. The allocation concealment was done using sealed sequentially numbered containers opaque envelope technique and the identical-looking container was used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesiology and Critical care

Model Details: a prospective randomized single-blind study. Patients were blind to the study of drugs. Blinding was achieved by the examiner of the study. Participants were randomly allocated into two groups (Group - B i.e. Bupivacaine Group and Group - R i.e. Ropivacaine group) using computer-generated randomization and allocation concealment was done using sealed sequentially numbered containers opaque envelope technique (SNOSE)

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 29, 2021
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share