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Clinical Trials/CTRI/2024/05/068224
CTRI/2024/05/068224Not yet recruitingPhase 2

An Open Label Randomised Trial Comparing Low Dose Of Dexmedetomidine As An Adjuvant To Isobaric Bupivacaine 0.0625% In Comparison With Plain Bupivacaine 0.125% To Assess Quality Of Postoperative Analgesia And Recovery In Abdominal And Lower Limb Surgeries

Nayana Sabu1 site in 1 country60 target enrollmentStarted: June 24, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Quality of analgesia using subjective tool-VAS scale and objective pain assessment tool- salivary alpha amylase level

Study Overview

Brief Summary

This thesis focuses on addressing post-operative pain management, recognizing its critical role in

preventing adverse outcomes such as elevated blood pressure, delayed recovery, increased risk of

chronic pain, and post-traumatic stress disorder (PTSD). Departing from conventional opioid use

due to associated adverse effects, the study introduces a novel approach involving

dexmedetomidine, a non-opioid adjuvant, in epidural analgesia.

Epidural analgesia is chosen for its advantages, including early mobilization, accelerated

recovery of gastrointestinal function, and reduced pulmonary and cardiovascular morbidity. The

primary aim of the study is to compare postoperative analgesia achieved through epidural

infusion of dexmedetomidine as an adjunct to low-dose isobaric bupivacaine versus the

conventional dose of plain isobaric bupivacaine. The primary objective is to assess the quality of

analgesia using subjective and objective pain assessment tools.The secondary objectives include

evaluating hemodynamic stability, degree of motor blockade, and the incidence of adverse

effects.

The maximum sample size that could be obtained based on VAS score, using the formula of

Mean Difference, power of 80%, two-sided confidence interval of 95% and using the 48 hour

VAS-R score from the parent study is n = 29 and 25 is the minimum number per group.

Two treatment arms are established, involving different combinations of bupivacaine and

dexmedetomidine, and randomization is achieved through a block randomization technique.

Patient inclusion criteria focus on ASA grade 1 and 2 individuals aged 18-60 undergoing specific

surgeries, while exclusion criteria encompass various conditions, including bleeding disorders

and coagulopathies. The study timeline spans over 18 months, including approval from the

Institutional Ethics Committee, preparation of study tools, a pilot study, data collection, analysis,

interpretation, and submission of the thesis. Ethical considerations underscore the importance of

informed, written, and verbal consent, as well as the option for participants to opt out at any

point in the study. Overall, the research aims to enhance postoperative pain relief while

minimizing adverse effects, contributing valuable insights to the field of anesthesia and pain

management.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Abdominal and lower limb surgeries ASA grade 1 and 2 Adults.

Exclusion Criteria

  • Bleeding disorders and coagulopathies Pregnancy raised ICT Altered sensorium Preexisting Bradycardia Hypotension.

Outcomes

Primary Outcomes

Quality of analgesia using subjective tool-VAS scale and objective pain assessment tool- salivary alpha amylase level

Time Frame: 0 HR | 1 HR | 2 HR | 6 hr | 12 hr | 24 hr

Secondary Outcomes

  • Hemodynamic instability(pulse rate, mean arterial BP ,respiratory rate, Ritchmond Almond Sedation scale ,spo2)(0 hr ,2 hrs ,6 hrs , 12 hrs, 24hrs)
  • Degree Of Motor Block(0 hr)
  • Incidence of adverse effects(Upto 24 hrs)
  • Requirement Of Rescue Analgesic(upto 24 hours)

Investigators

Sponsor
Nayana Sabu
Sponsor Class
Other [Self ]
Responsible Party
Principal Investigator
Principal Investigator

Nayana Sabu

AIIMS NAGPUR

Study Sites (1)

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