ClinicalTrials.gg
CompletedNCT07252817Updated Dec 5, 2025

Intensive Monitoring of Post-surgery Pain in Major Ambulatory Surgery

An interventional study of Intensive monioring group and Standard monitoring group in Hernioplasty, Cholecystectomy, Laparoscopic and Haemorrhoidal Surgery, sponsored by Consorci Sanitari del Maresme. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Feb 2025, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 341 studies in Pain with a site in Spain — 58 open to participants now, 68 under way, 7 of them phase 3. Pain · Spain.

Enrollment
39th of 295
280 · median 60
Started
2025
with 23 others
No phase
206 of 341
39 open now
Registered
313th of 341
by date

Among the 341 studies in Pain with a site in Spain, this one is the 39th largest by enrollment of the 295 interventional ones that give a count, is one of 24 that started in 2025, is one of 206 with no phase, and was the 313th registered.

Pain

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

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Open to participants now

58 of the 341 studies in Pain with a site in Spain are open now. Recruiting first, the newest first:

53 more — sign in →

All 58 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

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

Browse trials for

Keywords

  • Pain
  • Post-surgery pain
  • pain control
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients ≥ 18 years old.
  • .
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
280 participants (actual)

Study arms

  • Active comparator
    Standard monitoring group

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

    Other: Standard monitoring group

  • 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

Interventions

  • OtherIntensive 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).

  • OtherStandard monitoring group

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

06

What researchers measure

Primary outcomes

  1. Quality of Recovery

    Quality of Recovery (QoR15 test)

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

Secondary outcomes

  1. Pain Control by Visual Analogic Scale

    Visual Analogic Scale of pain. Range values: 0 (minium pain) thru 10 (maximum pain)

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

  2. 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.

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

  3. Adherence to prescribed analgesic treatment

    4-level Likert scale according to the patient's criteria: no adherence, low adherence, moderate adherence, and total adherence.

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

07

Study locations

1 site
  • Consorci Sanitari del Maresme
    Mataró, Barcelona 08304, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Aug 2025, 5 months.

Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 5 months is below that.

Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Nov 28, 2025
StartActual
Feb 17, 2025
Primary completionActual
Aug 5, 2025
CompletionActual
Aug 15, 2025
Last update
Dec 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07252817
Lead sponsor
Consorci Sanitari del Maresme
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Feb 17, 2025
Primary completion
Aug 5, 2025
Completion
Aug 15, 2025
Last update
Dec 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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