Evaluating the Effect of Opioid-sparing Anesthesia versus Opioid-based Anesthesia on Pain Intensity and Recovery Outcomes after Laparoscopic Surgery

To compare the analgesic efficacy and recovery profile of opioid‑based anesthesia versus opioid‑sparing anesthesia in adult patients undergoing elective laparoscopic surgery.

A randomized controlled clinical trial, with parallel groups, double‑blinded (patient and outcome assessor), phase 4, conducted on 100 patients (50 in each group). Randomization will be performed using a simple randomization method with a 6‑faced die and a 1:1 allocation ratio.

patients will be allocated to OBA and OSA groups. On surgery day, anesthesia is given per group: OBA receives fentanyl, OSA receives ketamine, dexmedetomidine, and local anesthesia. Vital signs are recorded at set times. After surgery, patients go to PACU for 24‑hour monitoring of pain, nausea, Aldrete score, opioid use, and adverse events. Patient satisfaction is also assessed. The study takes place at Al‑Shatrah General Hospital, Dhi Qar, Iraq.

Inclusion Criteria: -Age: Between 18 and 65 years (. -ASA Physical Status: Class I or II . Elective laparoscopic surgery -Ability to understand and sign informed consent: Exclusion Criteria: -ASA Physical Status Class III or higher. -History of allergy or contraindication to any drug used in either anesthetic technique. -Opioid abuse or chronic use of narcotics. -Significant cardiopulmonary, hepatic, or renal disease. -Pregnancy or lactation. -Cognitive impairment or psychiatric illness -BMI > 35 kg/m²

Patients are divided into two groups. The first group receives standard opioid‑based anesthesia, meaning opioids are used both during anesthesia and after surgery for pain control. The second group receives opioid‑sparing anesthesia,

Postoperative pain intensity (NRS) at 0, 1, 2, 4, 6, 8, and 12 hours after surgery.

Eligible patients meeting the inclusion criteria, following final confirmation of eligibility (which occurs after preoperative assessments and is typically determined 2–3 days prior to surgery), will be allocated to one of two intervention groups in a 1:1 ratio using simple randomization with a 6-faced die on the day of surgery, after patient transfer to the operating room, but prior to anesthesia induction. Accordingly, an individual independent of the research team will roll the die immediately after patient transfer to the operating room and before any therapeutic intervention, and based on the number shown, the patient will be randomly assigned to one of the two groups (numbers 1, 2, and 3 = Group A; numbers 4, 5, and 6 = Group B). The treatment team will be immediately informed of the patient's group assignment and will apply the anesthesia protocol and treatment regimen appropriate to the intervention or control group. The allocation of each patient will be performed entirely independently of previous allocations.

In this study, a full blind design is not feasible because the anesthesiologist must know which drugs to administer to the patient. Therefore, patient and outcome assessor blinding is applied: Patient (Blinded): The patient is unaware of their group assignment (whether they are receiving opioid-based anesthesia or opioid-sparing anesthesia). All drugs are administered in such a way that the patient cannot distinguish the difference. Outcome Assessor (Blinded): The personnel who record pain intensity, nausea and vomiting, Aldrete scores, and other outcomes in the recovery room and surgical ward are not informed of the patient's group. These individuals have no role in the anesthesia process and only collect data according to the study protocol. Anesthesiologist and Anesthesia Technician (Unblinded): These individuals are aware of the patient's group because they need to prepare and administer the appropriate drugs. However, they are not involved in outcome assessment or data analysis. Statistical Analyst (Blinded): The person or team performing the final data analysis will remain unaware of group assignments until the analysis is finalized. Data will be provided using numerical codes without group labels.

All data will remain confidential in accordance with the ethical commitment, and only aggregated group-level results will be published in the form of a final article or report.

Individual participant data will not be shared. The only publishable documents include the aggregated study results in the form of the final manuscript and the Statistical Analysis Plan (SAP). Study results will be disseminated through publication in a reputable national or international peer-reviewed journal in the field of anesthesiology, as well as presentation at relevant scientific conferences

Access to SAP: immediately after IRCT registration. Access to aggregated results (manuscript): submitted within 12 months of data collection completion; publicly available 6 months post-publication

IPD will not be shared. Aggregated results (manuscript) and SAP will be publicly and unrestrictedly available to all—academic researchers, industry professionals, students, and the public—via the publishing journal and IRCT.

IPD will not be shared. For use of aggregated results and SAP: 1. Proper citation is mandatory. 2. Direct commercial use is not permitted. 3. Compliance with research ethics is required. 4. No formal request is needed due to open-access publication.

Applicants, in order of priority: 1. Publishing journal website (manuscript). 2.. Principal investigator email . 3. PubMed, Scopus, and Google Scholar.

En No application process. Immediate, free download from journal website or Email inquiries