Comparison of Pain Relief by Bupivacaine With Dexmedetomidine and Bupivacaine Alone in Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries.
Phase: NA
Conditions: Pain, Postoperative
Sponsor: Sheikh Zayed Medical College

STUDY PROTOCOL AND STATISTICAL 
ANALYSIS PLAN 
 
Official Study Title: 
Comparison of pain relief by bupivacaine with dexmedetomidine and bupivacaine alone in 
transversus abdominis plane block for postoperative analgesia in patients undergoing abdominal 
surgeries 
NCT Number:  
Pending 
Document Type: 
Study Protocol and Statistical Analysis Plan 
Document Date: 
May 23, 2024 
Sponsor / Institution: 
Sheikh Zayed Medical College and Hospital, Rahim Yar Khan 
Principal Investigator: 
Rameesha Musharaf 
Post Graduate Resident (PGR) 
Department of Anesthesia, Sheikh Zayed Medical College and Hospital, Rahim Yar Khan 
 
 
 

Study Synopsis 
Introduction 
This future study aims to evaluate the efficacy of combining bupivacaine with dexmedetomidine 
for post-operative analgesia, compared to bupivacaine alone, in patients undergoing abdominal 
surgery. The methodology will follow Flick's (2015) research framework, ensuring rigorous data 
collection and thorough analysis. This research will focus on evaluating pain relief and safety 
outcomes for post-surgical patients. 
Research Philosophy 
The study will adopt a positivist perspective, focusing on objective data collection and unbiased 
analysis. This approach aims to minimize researcher bias, as discussed by Park et al. (2020) and 
Corry et al. (2019), ensuring the objectivity of the medical outcomes. While this approach limits 
context-dependent insights, it will ensure that results are impartial, particularly in the management 
of post-surgical pain, as proposed by Ryan (2018). 
Research Design 
The study will use a quantitative research design, in alignment with the positivist approach, 
prioritizing numerical data and statistical analysis (Queiros et al., 2017). This design will allow for 
broader generalizations and has been validated for its reliability and replicability, ensuring that 
findings will be applicable to future similar studies. 
Study Design 
A Randomized Controlled Trial (RCT) design will be employed, following the CONSORT 
guidelines to reduce bias through random selection and allocation of treatments (CONSORT, 
2017). This randomized design will ensure the validity and reliability of the study results. 
Study Site and Duration 
The study will take place at Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, 
selected for its accessibility and the researcher's familiarity with the institution. The trial will span 
four months, which will be sufficient for data collection, including baseline measurements and 
post-operative assessments. 
Data Collection 
Primary data collection will be utilized, focusing on direct clinical data to ensure the study's 
medical relevance. As noted by Hariton and Lucascio (2018), primary data improves the 
effectiveness of medical research. Key data points will include heart rate, mean arterial pressure, 
Visual Analogue Scale (VAS), and sedation levels, measured at various intervals post-surgery. 
Sampling 
The study will use non-probabilistic consecutive sampling, with patients selected based on 

specific inclusion and exclusion criteria. Participants will be randomly assigned to two groups 
using a lottery method, minimizing researcher bias. The sample size will be calculated using VAS 
ratings, targeting 80 participants. 
Methodology (Data Collection Procedure) 
Once ethical approval is obtained, volunteers will be recruited from the Anesthesia Department 
for elective surgeries. Standard pre-operative monitoring will be implemented, and a TAP block 
will be administered using either bupivacaine with dexmedetomidine or bupivacaine alone. Post-
operative follow-up will involve assessing pain, sedation, and adverse effects at predetermined 
intervals. 
Data Analysis 
Data analysis will be conducted using SPSS v23 to assess correlations and differences among 
variables. T-tests will be used to evaluate the significance of changes in pain (VAS), heart rate, 
and secondary outcomes. Chi-square tests will be used for categorical data, and stratification 
will control for potential confounders. 
Ethical Considerations 
Ethical approval will be obtained, and informed consent will be secured from all participants, 
ensuring they fully understand the study procedures. Participant confidentiality will be maintained 
through data coding, and all medical procedures will adhere to ethical guidelines to safeguard the 
participants’ safety and welfare.