Intensive Monitoring of Post-surgery Pain in Major Ambulatory Surgery

Seguimiento Intensivo Del Dolor Postoperatorio en cirugía Mayor Ambulatoria: Estudio de Viabilidad y Resultados

Moderate to severe acute postoperative pain (APP) during part of the postoperative period is a barrier that hinders the central objective of perioperative medicine, which is to achieve an optimal postoperative recovery process. Despite advances in perioperative medicine, a large proportion of post-operative patients continue to suffer from moderate to severe APS during many of the days of their convalescence. This poor control of APS, in addition to causing suffering and exposing the patient to an increased risk of complications, could impair the quality of post-surgical recovery , according to some authors. We therefore consider it to be of utmost interest in our field to corroborate whether the implementation of measures to better control DAP is related to a better quality of post-surgical recovery.

Currently, the growing trend to take into account the perspective of patients in their care has prompted the development of various patient-centred measurement tools that, among other aspects, assess the quality of post-surgical recovery. Several scales have been designed. The most widely used are the QoR-40, QoR-9 and QoR-15 scales. The latter, with a range of 0 to 150, was developed to simplify assessment, especially in telephone follow-ups, and has a reliability similar to its predecessor, the QoR-40.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy, Laparoscopic; Knee Arthroscopy; Shoulder Arthroscopy; Hernioplasty; Haemorrhoidal Surgery
• Intervention / Treatment: Other: Standard monitoring group; Other: Intensive monioring group

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Consorci Sanitari Del Maresme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ≥ 18 years old.
• ASA I - III.
• Scheduled for the surgeries: Laparoscopic or open inguinal hernia repairs, Laparoscopic cholecystectomies, Haemorrhoid surgeries, Knee arthroscopies, Shoulder arthroscopies.
• Willingness to be contacted by telephone during the duration of the study.
• Informed written consent to participate in this study.

Exclusion Criteria:

• Lack of proficiency in Spanish.
• Undergoing study or follow-up for moderate to severe cognitive impairment.
• Pregnant or breastfeeding patients.
• Patients on major opioid medication.
• Patients with a history of dependence/abuse of alcohol or illicit drugs at present.
• Patients under active follow-up by the chronic pain unit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard monitoring group; Routine follow-up (telephone call on the morning after surgery)	Other: Standard monitoring group; Routine follow-up (telephone call on the morning after surgery).
Experimental: Intensive monitoring group; Routine follow-up (telephone call on the morning after surgery) and Intensive follow-up of acute post-surgery pain.	Other: Intensive monioring group; Routine follow-up (telephone call on the morning after surgery) and Intensive follow-up of acute post-surgery pain (telephone call every day since pain resolution).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery	Quality of Recovery (QoR15 test)	Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of pain control	A 4-level Likert scale will be used according to the patient's criteria: dissatisfied, slightly dissatisfied, fairly satisfied, completely satisfied.	Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Adherence to prescribed analgesic treatment	4-level Likert scale according to the patient's criteria: no adherence, low adherence, moderate adherence, and total adherence.	Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Pain Control by Visual Analogic Scale	Visual Analogic Scale of pain. Range values: 0 (minium pain) thru 10 (maximum pain)	Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Actual): August 5, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Estimated): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pain; pain control; Post-surgery pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Agnosia
• Other Study ID Numbers: CEIm04/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No