HernioplastyNCT07252817
Intensive Monitoring of Post-surgery Pain in Major Ambulatory Surgery
A study testing Intensive monioring group and Standard monitoring group in people with Hernioplasty and Cholecystectomy, Laparoscopic, run by Consorci Sanitari del Maresme at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernioplasty, Cholecystectomy, Laparoscopic, Haemorrhoidal Surgery
- What is being tested?
- Intensive monioring group and Standard monitoring group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hernioplasty, Cholecystectomy, Laparoscopic, Haemorrhoidal Surgery, Knee Arthroscopy, Shoulder Arthroscopy
- Being tested
- Intensive monioring group, Standard monitoring group
- Keywords
- Pain, Post-surgery pain, pain control
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive monioring groupOther
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).
Standard monitoring groupOther
Routine follow-up (telephone call on the morning after surgery).
| Study group | Role | What they receive |
|---|---|---|
| Standard monitoring group | Active comparator | Routine follow-up (telephone call on the morning after surgery) Receives: 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. Receives: Other: Intensive monioring group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of Recovery (QoR15 test)
Measured: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Secondary outcomes (3)
Pain Control by Visual Analogic Scale
Visual Analogic Scale of pain. Range values: 0 (minium pain) thru 10 (maximum pain)
Measured: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
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.
Measured: 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.
Measured: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start17 Feb 2025
- Primary completion5 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HernioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252817
- Sponsor's protocol ID
- CEIm04/25
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seguimiento Intensivo Del Dolor Postoperatorio en cirugía Mayor Ambulatoria: Estudio de Viabilidad y Resultados
- ClinicalTrials.gov ID
- NCT07252817
- Acronym / sponsor ID
- CEIm04/25
- Conditions
- Hernioplasty, Cholecystectomy, Laparoscopic, Haemorrhoidal Surgery, Knee Arthroscopy, Shoulder Arthroscopy
- Keywords
- Pain, Post-surgery pain, pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard monitoring group | Active comparator | Other: Standard monitoring groupRoutine follow-up (telephone call on the morning after surgery) |
| Intensive monitoring group | Experimental | Other: Intensive monioring groupRoutine follow-up (telephone call on the morning after surgery) and Intensive follow-up of acute post-surgery pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive monioring groupRoutine 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). | Other | Intensive monitoring group |
| Standard monitoring groupRoutine follow-up (telephone call on the morning after surgery). | Other | Standard monitoring group |
Primary outcome
Quality of Recovery
Time frame: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Quality of Recovery (QoR15 test)
3 secondary outcomes
Pain Control by Visual Analogic Scale
Time frame: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Satisfaction of pain control
Time frame: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Adherence to prescribed analgesic treatment
Time frame: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive monioring group and Standard monitoring group in people with Hernioplasty and Cholecystectomy, Laparoscopic, run by Consorci Sanitari del Maresme at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.