NCT07547618

Brief Summary

Postoperative pain remains a significant clinical challenge that directly affects patient recovery, functional outcomes, and overall quality of care. Inadequate pain control in the early postoperative period is associated with delayed mobilization, increased risk of complications, prolonged hospital stay, and the development of chronic pain. The post-anesthesia care unit (PACU) represents a critical phase in which pain is actively assessed and managed, and analgesic consumption during this period serves as an objective indicator of analgesic requirements and effectiveness of perioperative pain strategies. This prospective observational study aims to identify patient-related, surgical, and anesthesia-related factors influencing analgesic consumption in the early postoperative period among adult patients admitted to the PACU following elective surgery. No additional interventions will be performed, and all perioperative management will follow routine clinical practice. Data will be collected prospectively from clinical records, anesthesia charts, and PACU monitoring forms. The primary outcome is total analgesic consumption during the PACU stay. Secondary outcomes include pain intensity assessed using a standardized pain scale at PACU admission and discharge, requirement for rescue analgesia, incidence of postoperative nausea and vomiting, and length of stay in the PACU. The findings of this study are expected to contribute to the identification of patients at higher risk for increased analgesic requirements and to support the development of individualized pain management strategies, ultimately improving perioperative care quality and patient outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 5, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 17, 2026

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Analgesic Consumption in the PACU

    Total amount of analgesic medications administered to patients during their stay in the post-anesthesia care unit (PACU). Analgesic consumption will be recorded and standardized (e.g., converted to morphine equivalents if applicable) to allow comparison across patients.

    During PACU stay (from admission to discharge, within approximately 0-4 hours postoperatively)

Secondary Outcomes (5)

  • Pain Intensity at PACU Admission

    At PACU admission (within the immediate postoperative period)

  • Pain Intensity at PACU Discharge

    At PACU discharge (within approximately 0-4 hours postoperatively)

  • Requirement for Rescue Analgesia in the PACU

    During PACU stay (from admission to discharge, within approximately 0-4 hours postoperatively)

  • Incidence of Postoperative Nausea and Vomiting in the PACU

    During PACU stay (from admission to discharge, within approximately 0-4 hours postoperatively)

  • Length of Stay in the PACU

    During PACU stay (from admission to discharge, within approximately 0-4 hours postoperatively)

Study Arms (1)

PACU Observational Cohort

This study consists of a single observational cohort of adult patients undergoing elective surgery and subsequently monitored in the post-anesthesia care unit (PACU). No intervention is applied as part of the study. All patients receive standard perioperative care according to institutional clinical practice. Data on analgesic consumption, pain scores, and perioperative variables are collected prospectively to evaluate factors influencing analgesic requirements in the early postoperative period.

Other: Observational Assessment

Interventions

This is a non-interventional observational study. No experimental intervention is applied. All patients receive routine perioperative care according to institutional clinical practice. The study involves prospective collection and analysis of clinical data related to analgesic consumption and associated factors during the early postoperative period in the post-anesthesia care unit (PACU).

PACU Observational Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective surgical procedures and admitted to the post-anesthesia care unit (PACU) in a tertiary oncology hospital. The study population represents a heterogeneous surgical cohort managed under routine perioperative care conditions.

You may qualify if:

  • Adults aged 18 years and older
  • Undergoing elective surgical procedures
  • Admitted to the post-anesthesia care unit (PACU) after surgery
  • Receiving general and/or regional anesthesia
  • Able to provide informed consent

You may not qualify if:

  • Patients younger than 18 years
  • Emergency surgical procedures
  • Patients transferred directly to the intensive care unit postoperatively
  • PACU stay shorter than 30 minutes
  • Patients unable to communicate or assess pain
  • Incomplete clinical records
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

    PMID: 14667752BACKGROUND
  • Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

    PMID: 24356162BACKGROUND
  • Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

    PMID: 12873949BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Mustafa Kemal Şahin

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

April 5, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to institutional data protection policies and the need to maintain patient confidentiality. All data collected in this study will be anonymized and used solely for the purposes of this research.

Locations