Intensive Monitoring of Post-surgery Pain in Major Ambulatory Surgery

NCT ID: NCT07252817

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2025-08-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard monitoring group

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

Group Type: ACTIVE_COMPARATOR

Standard monitoring group

Intervention Type: OTHER

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

Intensive monitoring group

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

Group Type: EXPERIMENTAL

Intensive monioring group

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Standard monitoring group

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari del Maresme

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Countries

Spain

Other Identifiers

CEIm04/25

Identifier Type: -

Identifier Source: org_study_id