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
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
Nayana Sabu
AIIMS NAGPUR
