COMPARISON OF THE EFFECTIVENESS OF NALBUPHINE VERSUS TRAMADOL FOR PREVENTION OF POST SPINAL SHIVERING IN PATIENTS UNDERGOING LOWER LIMB SURGERY AT TERTIARY CARE HOSPITAL, KARACHI

The main aims are: 1. To assess the incidence of post-spinal shivering in patient 2. To evaluate the efficacy . 3. To compare the safety profiles in the study population 4. To determine the optimal pharmacological approach for shivering prophylaxis in lower limb surgery patients. This study hypothesize that nalbuphine is better in effective controlling post-spinal anesthesia shivering compared to tramadol. The findings of this study will provide valuable understanding of effectiveness between nalbuphine and tramadol, and helpful for other anesthetist to optimizing perioperative care also reducing the risks of postoperative complications

- Randomized Controlled Trial (RCT) - Parallel-group design - Single-center study - double-blinding (participants and outcome assessors blinded) - Prospective study

1. Study location: Department of Anesthesia, National Medical Center, Karachi. 2. Country: Pakistan. 3. Tertiary care hospital.

Inclusion Criteria: 1. Patients of either sex. 2. Age 20-60 years. 3. Scheduled for lower limb surgery under spinal anesthesia. 4. American Society of Anesthesiologists (ASA) physical status ≤ 2. Exclusion Criteria: 1.Emergency surgeries, deformities of the spine, hypersensitivity to any of the drugs in the study. 2.Thyroid or neuromuscular diseases. 3.Patients on narcotics/sedatives. 4. Allergic to nalbuphine or tramadol. 5.Patients with an initial body (core) temperature >38.0°C or <36.0°C. 6.History of stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, and CCF

Nalbuphine group (N) and Tramadol group (T) both receiving dose of (0.5mg/kg) intravenously over 5 minutes which is administrated after spinal anesthesia and assessed via shivering grade (0-4)

Incidence of post-spinal shivering (yes/no)

The method used is block Randomization in which using a technique of sealed opaque envelopes (SOE) to minimize selection bias, ensure comparable groups, and reduce confounding variables. Eligibility of participants are stratified by age, sex and surgery type, then randomly allocated to either Nalbuphine or Tramadol groups The randomization procedure are : 1.Assessing eligibility and obtaining informed consent 2.Stratifying participant 3.Using SOE for treatment assignment 4.Randomly allocating participants to treatment groups.

- Sealed opaque envelopes bearing "N" (Nalbuphine) or "T" (Tramadol) are used for randomization. - Participants and outcome assessors are unaware of the treatment assignments.

"Nalbuphine-Tramadol Trial Dataset" Participant Data Sets: - Demographics (age, sex, weight, height) - Clinical outcomes (shivering assessment, vital signs, adverse events) - Intervention details (nalbuphine/tramadol dosage, administration time) - Follow-up data (post-operative shivering, pain scores). Specific IPD Shared: - All collected de-identified IPD for primary and secondary outcome measures - IPD collected for adverse events and serious adverse events Proforma: - Participant ID (anonymized) - Treatment group (nalbuphine/tramadol) - Shivering assessment (yes/no) - Vital signs (heart rate, blood pressure, temperature) - Adverse events (yes/no)

6 months after completion of study

It will available for Institutional Review Board (IRB). College of Physician and Surgeon Pakistan (CPSP) .

Publication in peer-reviewed journals Education and training / Research purpose Presentation at Scientific conference

National Medical Center, Karachi. Study website (After Publication) Institutional review board (IRB)

Study Principal Investigator/ Data Sharing Committee approves or rejects request. Requester is notify via email (approval/ Rejection)