Efficacy of Intraoperative Dexamethasone Infusion in Mitigating Shoulder Pain and Postoperative Nausea and Vomiting Following Laparoscopic Hysterectomy

Efficacy of Intraoperative Dexamethasone Infusion in Mitigating Shoulder Pain and Postoperative Nausea and Vomiting Following Laparoscopic Hysterectomy

This study is a randomized, double-blind, phase 2-3 clinical trial with parallel groups conducted on 130 patients undergoing laparoscopic hysterectomy at Taleghani Hospital, Tabriz. Patients will be randomly assigned, using block randomization with blocks of four, into two groups. The intervention group will receive intraoperative intravenous dexamethasone infusion, while the control group will receive placebo (normal saline). The intervention will be administered by the anesthesiologist, and the effect of dexamethasone infusion on postoperative shoulder pain as well as nausea and vomiting will be evaluated and compared.

It is a randomized, double-blind, placebo-controlled clinical trial. Three minutes after anesthesia induction, the intervention is administered intravenously over 10 minutes: the intervention group receives dexamethasone (0.2 mg/kg), while the control group receives placebo (normal saline).

Inclusion criteria: Women aged 15 to 65 years scheduled for laparoscopic hysterectomy who have provided written informed consent for study participation. Exclusion criteria: Patients with a history of hypertension or known hypersensitivity to dexamethasone.

In this study conducted at Taleghani Hospital, Tabriz, women undergoing laparoscopic hysterectomy will be randomly assigned to two groups: the intervention group, receiving intraoperative dexamethasone infusion, and the control group, receiving placebo (normal saline). The main outcomes include shoulder pain and postoperative nausea and vomiting.

Pain intensity

In this study, with a sample size of 130, participants will be assigned to three groups using permuted block randomization. A block size of four will be employed, utilizing all possible combinations, including: Block 1 (BBAA), Block 2 (AABB), Block 3 (ABAB), Block 4 (BABA), Block 5 (ABBA), and Block 6 (BAAB). To accommodate 130 participants, 33 blocks will be generated using Random Allocation Software, with blocks randomly selected from numbers 1 to 6. For instance, if block 6 and block 2 are selected sequentially, the allocation sequence will be BAABAABB, assigning individuals to Intervention Group (A), Intervention Group (B), and the Control Group.

In this study, to ensure proper patient blinding, the medications for groups A and B will be prepared in identical appearance, color, packaging, and administration method, making them indistinguishable to participants. Each medication will be labeled with a unique code (A or B), known only to an independent researcher who is not involved in patient recruitment or evaluation. The envelopes containing the coded medication will be provided to the study investigator in sequential order, without any indication of treatment type. Consequently, both patients and the investigator will remain unaware of group allocation, thus maintaining a practical and effective double‑blind design throughout the trial.