An interventional study of Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy in Cholelithiasis and Postoperative Pain, sponsored by Muğla Sıtkı Koçman University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Muğla Sıtkı Koçman University · Not applicable, Interventional, and Other
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.
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.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 142 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will follow the pain management protocol after laparoscopic cholecystectomy, including recording postoperative pain in a pain diary.
Behavioral: Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy
Participants in this group will receive standard care after laparoscopic cholecystectomy. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at scheduled times by nurses and researchers, and recorded accordingly
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.
Postoperative Pain Intensity and Pain Diary vs. VAS Comparison
The primary outcome measure involves postoperative pain intensity recorded by patients in the intervention group using a daily pain diary, compared to routine clinical VAS measurements in the control group. Measurements will be taken at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours post-surgery. Additionally, short pain inventories at 24 and 48 hours and VAS-based satisfaction evaluation before discharge will be performed.
Time frame: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a 0-10 Likert scale (VAS). In the intervention group, patients will record their pain in a daily pain diary at scheduled times, while in the control group, routine clinical VAS measurements will be performed. Additionally, short pain inventories at 24 and 48 hours and VAS-based satisfaction evaluation before discharge will be conducted
Time frame: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)
Plan to share: Yes — The specific individual patient data collected in this study include patient first and last names, signed informed consent forms, socio-demographic information (age, gender, etc.), medical history, and postoperative pain diary data. These data will be used solely for research purposes and shared in accordance with confidentiality principles
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Individual patient data and supporting information will be accessible from the date patients provide informed consent prior to surgery, throughout the data collection period, and for at least 5 years following study completion, stored in accordance with confidentiality principles
Access criteria: Individual patient data and supporting information will be accessible only to the study research team. The research team will have access to patient names, surnames, socio-demographic information, medical history, and pain diary data via a secure, password-protected electronic database. The data will be used solely for study purposes and will not be shared with third parties
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jul 2026, 8 months after the start.
Of 54 non-industry interventional studies with no phase under Cholelithiasis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 8 months is below that.
Counting every sponsor, half of 58 studies reached it within 15 months; a quarter within 6 and three quarters within 24.
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