“Pre-emptive analgesia with Ibuprofen in outpatient laparoscopic cholecystectomy. Recovery Quality ”

“Pre-emptive analgesia with Ibuprofen in outpatient laparoscopic cholecystectomy. Recovery Quality ” - PREEMTIVE

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002779-32-ES

Enrollment

Registered

2019-11-11

Start date

2019-12-26

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AMBULATORY LAPAROSCOPIC COLECISTECTOMY

Interventions

Trade Name: SOLIBU 400 MG Product Name: SOLIBU 400MG SOLUCIÓN Pharmaceutical Form: Solution for injection INN or Proposed INN: IBUPROFEN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? That is over 18 years, of both sexes, ASA I-III. ? Accept participation in the study (CI that will be signed by the patient or relative depending on the degree of autonomy of the patient). ? All patients who will undergo laparoscopic cholecystectomy in the CMA unit will be included for 2 years from the start date of the study in the center. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -History of allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs). -Chronic use of opioids or NSAIDs. -Severe liver or kidney insufficiency. -History of hemorrhagic diathesis, history of gatrointestinal bleeding, peptic ulcer or inflammatory bowel disease. -Pregnancy or breastfeeding. -Patients undergoing coronary revascularization surgery, patients with severe heart failure (HF) or ischemic cardiomyopathy. -History or hypersensitivity history to Pyrazolones or Paracetamol. -Open cholecystectomy (laparotomy).

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the efficacy of the treatment according to the NSAID administration schedule, before and after the surgical aggression. For this, it is desired to know if there is a significant difference in the consumption of Fentanyl (in ug) between the two groups to be evaluated in the study.;Secondary Objective: In addition to the main objective of the study, we want to assess whether the difference in treatment between the two groups of patients has consequences on other variables of interest such as T1, recovery quality (QoR-15), ENV, NVPO, TURPA , TSAM. Adverse effects will be recorded with ibuprofen ev administration.;Primary end point(s): Morphic consumption in the immediate postoperative period;Timepoint(s) of evaluation of this end point: Total consumption of Fentanyl (ug) in the immediate postoperative period (from the end of surgery until discharge from CMA).	—

Measure

Time frame

Main Objective: Compare the efficacy of the treatment according to the NSAID administration schedule, before and after the surgical aggression. For this, it is desired to know if there is a significant difference in the consumption of Fentanyl (in ug) between the two groups to be evaluated in the study.;Secondary Objective: In addition to the main objective of the study, we want to assess whether the difference in treatment between the two groups of patients has consequences on other variables of interest such as T1, recovery quality (QoR-15), ENV, NVPO, TURPA , TSAM. Adverse effects will be recorded with ibuprofen ev administration.;Primary end point(s): Morphic consumption in the immediate postoperative period;Timepoint(s) of evaluation of this end point: Total consumption of Fentanyl (ug) in the immediate postoperative period (from the end of surgery until discharge from CMA).

—

Secondary

Measure	Time frame
Secondary end point(s): Assess whether the difference in treatment between the two groups of patients has consequences on other variables of interest such as T1, recovery quality (QoR-15), ENV, NVPO, TURPA , TSAM. Adverse effects will be recorded with ibuprofen ev administration.; Timepoint(s) of evaluation of this end point: T1: Time, in minutes, from the end of the surgery until the first morphic rescue. • Quality of recovery through questionnaire QoR-15 (scale 0-10), 15 items) performed before surgery (Q0), at 24h (Q1) at 72h (Q2) and at week (Q3) • ENV (scale 0-10) at rest at 0h, 1h, 2h, 4h and at rest / movement at 6h, at discharge, at 24h, 72h and one week after surgery. • NVPO: Yes / No. Need for rescue medication: Yes / No • TURPA and TSAM in minutes. • Adverse reaction with the administration of Ibuprofen ev. • Surgery time. • Anesthesia time.	—

Measure

Time frame

Secondary end point(s): Assess whether the difference in treatment between the two groups of patients has consequences on other variables of interest such as T1, recovery quality (QoR-15), ENV, NVPO, TURPA , TSAM. Adverse effects will be recorded with ibuprofen ev administration.; Timepoint(s) of evaluation of this end point: T1: Time, in minutes, from the end of the surgery until the first morphic rescue. • Quality of recovery through questionnaire QoR-15 (scale 0-10), 15 items) performed before surgery (Q0), at 24h (Q1) at 72h (Q2) and at week (Q3) • ENV (scale 0-10) at rest at 0h, 1h, 2h, 4h and at rest / movement at 6h, at discharge, at 24h, 72h and one week after surgery. • NVPO: Yes / No. Need for rescue medication: Yes / No • TURPA and TSAM in minutes. • Adverse reaction with the administration of Ibuprofen ev. • Surgery time. • Anesthesia time.

—

Countries

Spain

Contacts

Public ContactCLINICAL RESEARCH PLATFORM

IIS BIODONOSTIA

LORENA.CODESIDOCISCAR@OSAKIDETZA.EUS

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026