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Intensive Monitoring of Post-surgery Pain in Major Ambulatory Surgery

C

Consorci Sanitari del Maresme

Status

Completed

Conditions

Shoulder Arthroscopy
Hernioplasty
Haemorrhoidal Surgery
Knee Arthroscopy
Cholecystectomy, Laparoscopic

Treatments

Other: Intensive monioring group
Other: Standard monitoring group

Study type

Interventional

Funder types

Other

Identifiers

NCT07252817
CEIm04/25

Details and patient eligibility

About

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.

Enrollment

280 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

280 participants in 2 patient groups

Standard monitoring group
Active Comparator group
Description:
Routine follow-up (telephone call on the morning after surgery)
Treatment:
Other: Standard monitoring group
Intensive monitoring group
Experimental group
Description:
Routine follow-up (telephone call on the morning after surgery) and Intensive follow-up of acute post-surgery pain.
Treatment:
Other: Intensive monioring group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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