Use of Bupivacaine with Tramadol is better than use of only Bupivacaine for post operative pain in Local Anesthesia

The aim of this study is to evaluate and compare the postoperative analgesic efficacy of bupivacaine alone versus a combination of bupivacaine and tramadol when used for local anesthesia in patients undergoing minor surgical procedures at a tertiary care hospital in Karachi. This research seeks to assess the mean postoperative pain following minor surgical procedures, as well as the need for rescue analgesia, in both groups, in order to determine whether the addition of tramadol provides superior pain control or not.

Parallel group, single blinded, randomized controlled trial.

The study was conducted at the Surgical Unit 4 of Jinnah Postgraduate Medical Center and was a single blinded study where the patients were unaware of which group they have been assigned to

INCLUSION CRITERIA: All patients undergoing elective procedure under local anesthesia Either gender. Age 18-60 years. EXCLUSION CRITERIA: Procedures Under general anesthesia. Diabetic patients, assessed by history and clinically and HbA1c >6.5% Patients with metastatic disease, assessed by history, clinically and by imaging. Patients who are I/V opioid abusers will be excluded.

In Group A (bupivacaine) patients received 0.5 ml/kg of 0.25% plain bupivacaine at the surgical site, while Group B (bupivacaine with tramadol) patient received 0.5 ml/kg of 0.25% bupivacaine in combination with 1 mg/kg of tramadol.

Mean postoperative pain score using a visual analogue scale

A simple randomization method (Lottery method) will be used. Unit of randomization will be individual. Randomization strata in stratified randomization will not be applicable. The tool used will be paper slips drawn randomly from a container. Other tools like a computer software will not be used. The random sequence will be generated by drawing lots (paper slips) from a shuffled container. Allocation concealment will be carried out.

In this study, single blinding will be implemented by ensuring that the patients (participants) are unaware of the treatment they received. The patients will be randomly assigned to either the Bupivacaine alone group or the Bupivacaine + Tramadol group using the lottery method. The anesthetic solutions will be prepared in identical syringes to prevent the patients from distinguishing between the two treatments. The patients will not be informed about which anesthetic they received, reducing the risk of reporting bias based on expectations. However, the researchers administering the anesthesia will be aware of the treatment assignments.

The study protocol outlines the methodology, objectives, and design of the research. Sharing Plan: The study protocol will be shared via email with collaborating researchers or institutions, with a link to a secure cloud storage service (e.g., Google Drive, Dropbox) where the document can be accessed and downloaded. After completion of the study, the protocol will be included as part of the publication in a peer-reviewed journal. Access Type: Open access for collaborators; the protocol will be shared as supplementary material in the publication. File Format: PDF or Word document.

Availability: The raw data will become available after the study has been completed and the manuscript has been accepted for publication. The anonymized data will be shared with the public and other researchers upon publication of the study in the peer-reviewed journal which is within 6 months of publication. Duration of Availability: The data will be made available indefinitely through public repositories such as the journal’s supplementary material section or a data repository (e.g., ResearchGate, PubMed, or a dedicated data repository like Dryad or Open Science Framework). Data will be accessible as long as the publication remains available or until the platform’s terms and conditions change. Access Type: Anonymized data will be made publicly accessible, ensuring that patient confidentiality is maintained.

Research Team: Full access to raw data will be available to the research team throughout the study period for analysis and reporting. Collaborators: Research collaborators, if needed for analysis or verification, will have access to the anonymized data after the study is completed and prior to publication. General Public: After publication, anonymized raw data will be made publicly available through the journal’s supplementary materials, public data repositories such as ResearchGate, Open Science Framework, or the publication platform like PubMed. Other Researchers: The data will be made available to researchers interested in replicating or extending the study, with access to anonymized data for academic purposes.

Academic and Research Purposes: The raw data can be used by other researchers for further analysis, replication studies, or meta-analyses as long as the data is anonymized to maintain patient confidentiality. Publications: Data may be used for secondary publications, such as follow-up studies or papers that compare the study’s results with other research. Educational Use: The data can be used in academic settings like for teaching purposes in courses or training as long as appropriate references to the original study are made. Non-Commercial Use: Data can only be used for non-commercial purposes unless otherwise specified in the data-sharing agreement. Ethical Considerations: The data cannot be used for any purpose that might violate the privacy of the participants or compromise the integrity of the study

Data can be requested from the corresponding author of the study after publication. Email Address: moosanl30@gmail.com The corresponding author will provide access to anonymized raw data through a secure platform such as cloud storage upon request for academic or research purposes.

The requester sends an email to the corresponding author at the provided email address. The requester should clearly specify the data or document they wish to access, the purpose of the request and any relevant ethical or institutional considerations.