NCT07308730

Pain Diary Use After Laparoscopic Cholecystectomy

Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Muğla Sıtkı Koçman University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled study aims to evaluate the effectiveness of using a pain diary in the assessment of early postoperative pain in patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to a pain diary group or a control group receiving routine pain assessment. Postoperative pain intensity will be measured at predefined time points using standardized pain assessment tools. The study seeks to improve patient participation in postoperative pain evaluation without introducing additional pharmacological interventions.

Detailed description

This is a single-center, randomized controlled trial conducted in patients undergoing elective laparoscopic cholecystectomy. Eligible patients are randomly assigned to either the intervention group or the control group using a block randomization method. In the intervention group, postoperative pain assessment is performed using a patient-completed pain diary. The pain diary is developed based on the literature and expert opinions and is introduced to patients during the preoperative period. Patients are instructed on how to complete the pain diary, and pain intensity is recorded at rest and during movement at predefined postoperative time points. In the control group, postoperative pain assessment is carried out using routine clinical practice with the Visual Analog Scale (VAS). Pain assessments are performed at the same postoperative time points as in the intervention group. Additional pain-related assessments are conducted in both groups during the postoperative period. To minimize contamination between groups, patients in the intervention and control groups are followed in separate hospital rooms. Due to the visible nature of the pain diary, blinding is not feasible in this study.

Conditions

• Cholelithiasis
• Postoperative Pain

Interventions

Type	Name	Description
BEHAVIORAL	Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy	This pain management protocol is specifically tailored for patients undergoing laparoscopic cholecystectomy and combines both scheduled pharmacological analgesics and non-pharmacological pain control measures. Unlike other studies, it includes daily pain diary monitoring to objectively track patient-reported postoperative pain and recovery outcomes.

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-07-30
• Completion: 2027-01-30
• First posted: 2025-12-30
• Last updated: 2026-01-06

Locations

1 site across 1 country: Turkey (Türkiye)