Intensive Monitoring of Post-surgery Pain in Major Ambulatory Surgery

NCT07252817 | Completed

• 1 other identifier: CEIm04/25
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernioplasty; Cholecystectomy, Laparoscopic; Haemorrhoidal Surgery; Knee Arthroscopy; Shoulder Arthroscopy

Keywords

Pain; Post-surgery pain; pain control

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  Quality of Recovery (QoR15 test)

  Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

Secondary Outcomes (3)

• Pain Control by Visual Analogic Scale

  Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

• Satisfaction of pain control

  Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

• Adherence to prescribed analgesic treatment

  Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

Study Arms (2)

Standard monitoring group

ACTIVE COMPARATOR

Routine follow-up (telephone call on the morning after surgery)

Other: Standard monitoring group

Intensive monitoring group

EXPERIMENTAL

Routine follow-up (telephone call on the morning after surgery) and Intensive follow-up of acute post-surgery pain.

Other: Intensive monioring group

Interventions

Intensive monioring group OTHER

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).

Intensive monitoring group

Standard monitoring group OTHER

Routine follow-up (telephone call on the morning after surgery).

Standard monitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Study Sites (1)

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: February 17, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 15, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)