PREVENTION OF POST-OPERATIVE PAIN WITH SUB-LINGUAL MORPHINE

PRE-EMPTIVE ANALGESIA E SURGICAL STRESS RESONSE WITH SUB-LINGUAL MORPHINE - ORAMORPH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018342-31-IT

Enrollment

300

Registered

2012-03-13

Start date

2010-01-12

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

surgical patient MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Oral Morphine Product Code: NA Pharmaceutical Form: Oral drops, solution INN or Proposed INN: MORPHINE SULPHATE Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - informed consent; - age between 18 and 80 y.o.; - ASA class I and II; - elective surgical operation, with length less than 6 hours Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130

Exclusion criteria

Exclusion criteria: - age less than 18 yo - ASA class IIi and IV - emergency surgical operation - antidepressive drugs - chronic renal failure (dyalis or creatinine more than 2 mg/dl) - morphine ipersensivity -pregancy and nursing - history of abuse of alcohol or delirium tremens - seizure history - chronic respiratory failure (PaO2 less 60 mmHg or PaCO2 more than 60 mmHg) - Severe hepatic failure (Child Pugh class III and IV)

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of premedication with sub-lingual morphine on post-operative pain control following Pre-emptive Analgesia;Secondary Objective: 1. reduction of consumption of analgesic drugs in post-operative period 2 reduction of surgical stress response (inflammatory response, cortisol plasmatic concentration, resistence to insulin) 3. faster mobilization of patient (reduction of hosptial lenght stay);Primary end point(s): - reduction of post-operative pain of 50% in patient premedicated with sub-lingual morphine (static and dynamic VAS less than 30) in videolaparoscopic and open surgery;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: evaluation of premedication with sub-lingual morphine on post-operative pain control following Pre-emptive Analgesia;Secondary Objective: 1. reduction of consumption of analgesic drugs in post-operative period 2 reduction of surgical stress response (inflammatory response, cortisol plasmatic concentration, resistence to insulin) 3. faster mobilization of patient (reduction of hosptial lenght stay);Primary end point(s): - reduction of post-operative pain of 50% in patient premedicated with sub-lingual morphine (static and dynamic VAS less than 30) in videolaparoscopic and open surgery;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): - reduction of IVPCA administered doses and failed doses of 40% in patient premedicated with sub-lingual morphine -reduction of morphine consumption of 40% with IVPCA in patient premedicated with sub-lingual morphine - reduction of aceatminophen rescue dose in patient premedicated with sub-lingual morphine;Timepoint(s) of evaluation of this end point: 48 hours	—

Countries

Italy

Contacts

Public ContactSEZIONE DI ANESTESIA E RIANIMAZIONE

AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI

araffaele.degaudio@unifi.it055434807

Outcome results

None listed

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