Efficacy and safety of intravenous lidocaine versus placebo associated with intrathecal morphine analgesia in major digestive or abdominal surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GCS Ramsay Sante Enseignement Et Recherche

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2025-06-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the superiority of IV lidocaine combined with morphine rachi anaesthesia compared with placebo combined with morphine rachi anaesthesia, in reducing morphine consumption postoperatively at 48 hours, in patients undergoing major digestive or abdominal surgery under laparotomy.

Secondary objectives 9

1. Compare the maximum intensity of post-operative pain over the last 12, 24, 48, 72 and 96 hours.
2. Assess the time taken for transit to resume in the 2 groups.
3. Assess and compare total IV morphine consumption at H12, H24, H72 and H96 between the 2 groups.
4. Evaluate the time of first rising in the 2 groups.
5. Evaluate and compare the duration of the intervention between the 2 groups.
6. Evaluate and compare the length of hospital stay between the 2 groups.
7. To assess the occurrence of morphine-related adverse events during and after surgery (H0, H12, H24, H48, H72 and H96).
8. Evaluate the occurrence of lidocaine-related adverse events during and after surgery (H0 and H12).
9. Evaluate other adverse events in the 2 groups throughout the duration of the trial.

Conditions and MedDRA coding

Major patients receiving morphine spinal anaesthesia for major gastrointestinal or abdominal surgery by scheduled laparotomy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥ 18 years
2. Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynaecological, oesophageal, gastric, duodenal, small intestine, etc.)
3. Scheduled intervention
4. Laparotomy
5. Patient in agreement with rachi morphine anaesthesia
6. Membership of a social security scheme
7. Signed informed consent

Exclusion criteria 17

1. Emergency surgery
2. Rhythm disorder at risk of sudden death (e.g. Brugada syndrome)
3. Flecaine as usual treatment
4. Chronic pain with level II or III analgesics
5. Contraindication to non-steroidal anti-inflammatory drugs: history of peptic ulcer disease, stage 3 A renal failure or more (DFG according to CKD EPI < 60 ml/min).
6. Previous bradycardia and/or known conduction disorder (atrioventricular block) / Pacemaker
7. Unstable coronary
8. Myocardial infarction <6 months
9. Severe cardiocirculatory insufficiency
10. Severe liver failure
11. Morphine allergy
12. Allergy to lidocaine
13. Gabapentinoids: pregabalin (Lyrica), gabapentin
14. Patient taking part in another clinical trial, or in a period of exclusion from another clinical trial
15. Inability to understand information relating to the study (for linguistic, psychological or cognitive reasons, or due to a lack of literacy skills)
16. Women who are or may become pregnant (of childbearing age, without effective contraception) or who are breast-feeding
17. Patient deprived of liberty or under guardianship or unable to give consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Total consumption of morphine received postoperatively from the post-interventional monitoring room to H48 (in mg) in IV by PCA (Patient Controlled Analgesia), and oral dose converted to equivalent IV morphine where appropriate

Secondary endpoints 9

1. Maximum score of the verbal numerical scale (scored from 0 to 10) at rest and during exertion (cough/mobilisation) over the last 12, 24, 48, 72 and 96 hours. The verbal numerical scale was collected every 4 hours after the end of the intervention until H96
2. Time between the end of the operation and the first gas described by the patient (in hours)
3. Total consumption of IV morphine at H12, H24, H72 and H96 in the 2 groups
4. Time of first rise in the 2 groups
5. Duration of surgery (in minutes), defined as the time from incision to closure
6. Length of hospital stay (in days)
7. Morphine-related adverse events by investigator (H0, H12, H24, H48, H72 and H96)
8. Lidocaine-related adverse events by investigator (H0 and H12)
9. Collection of adverse events in the 2 groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GCS Ramsay Sante Enseignement Et Recherche

Sponsor organisation

GCS Ramsay Sante Enseignement Et Recherche

Address

39 Rue Mstislav Rostropovitch

City

Paris

Postcode

75017

Country

France

Scientific contact point

Organisation

GCS Ramsay Sante Enseignement Et Recherche

Contact name

Anesthesiologist

Public contact point

Organisation

GCS Ramsay Sante Enseignement Et Recherche

Contact name

Anesthesiologist

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications