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Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

B

B.P. Koirala Institute of Health Sciences

Status and phase

Completed
Phase 3

Conditions

Brachial Plexus Block

Treatments

Drug: Ropivacaine and Dexamethasone
Drug: Ropivacaine and Normal saline
Drug: Ropivacaine and Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02787018
IRC/641/015

Details and patient eligibility

About

The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Full description

Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block

Exclusion criteria

  • Patient's refusal to participate
  • Patients weighing less than 40 kg
  • Allergy to study drugs
  • Infection at the site of injection
  • Patients with preexisting neurological deficit
  • Patients with diabetes mellitus
  • Patients on steroids preoperatively
  • Patients with bleeding disorder or coagulopathy
  • Abnormalities in ECG like AV block or symptomatic bradycardia
  • Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively
  • Requirement of conversion to general anesthesia due to inadequate block

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

120 participants in 3 patient groups, including a placebo group

Block with Ropivacaine and Normal saline
Placebo Comparator group
Description:
Patients will receive brachial plexus block with 20 ml 0.5% ropivacaine with 1ml normal saline: Total volume 21 ml
Treatment:
Drug: Ropivacaine and Normal saline
Block with Ropivacaine and Dexamethasone
Active Comparator group
Description:
Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml
Treatment:
Drug: Ropivacaine and Dexamethasone
Block with Ropivacaine and Dexmedetomidine
Experimental group
Description:
Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml
Treatment:
Drug: Ropivacaine and Dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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