Completed

DEXA-PG-HDDexamethasone and Pregabalin Co-analgesia for Postoperative Pain Reduction in Lumbar Slipped Disc Surgery

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Study Aim

This study aims to evaluate the effectiveness of Dexamethasone and Pregabalin co-analgesia in reducing postoperative pain in individuals undergoing lumbar slipped disc surgery, specifically during the first mobilization at the edge of the bed.

What is being tested

Pregabaline and Dexamethasone Treatment

+ Pregabaline and Dexamethasone Treatment

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pathologic Processes

From 18 to 85 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: August 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

Visit 1 (J-30 J-1): pre-inclusion visit During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection. Physician investigator check the eligibility criteria and complete a pre-screening form where he will note the following information about the patient: No pre-enrollment, name, date, reason for non-inclusion appropriate. Visit 2 (J-1): pre-anesthetic visit, the day before surgery During the pre-anesthetic routine consultation, the doctor will check the proper collection of informed consent and then inform the following information on the CRF: randomization number, age, height, weight, ideal weight theory, gender patient. Visit 3 (J0): surgery One hour before surgery, the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally. Then the patient will be conducted in the operating room for induction of general anesthesia and surgery. Immediately after induction of anesthesia, depending on randomization, the patient will receive intravenous dexamethasone or placebo. At the end of surgery, the patient is conducted in Post Anaesthesia Carry Unit (PACU) to be extubated and receive routine care after surgery. Extubation of the patient, denoted H0 represents the time when the measurement begins. The data collected from H0 are : * ENS score standing at H0, H0+30mn, H0+1h, H0+1h30, H0+2 h, H0+6 h,H0+12 h, H0+24h, H0+48 h. * ENS score mobilization at the first time the patient gets up (edge of the bed and standing if possible) * Qualification of the quality of standing 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good)) by the nursing staff after the first mobilization * Qualification of patient satisfaction compared to the first standing by a score of 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good)) * Sedation score at the end of SSPI, , at H0+24h and H0+48h * Nausea and vomiting score at H0+24 h, H0+48 h * Tolerance of the treatments undertaken : visual disturbances, lightheadedness, urinary retention, pruritus, measured at the end of SSPI at H0+24 h and H0+48 h * Consumption of morphine at H0+24 h and H0+48 h * Assessment of pain score at 6 months by score ENS at rest , assessment of neuropathic component by DN4 scale. Statement consumption of analgesic treatments.

NCT01811251
Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: August 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

162 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain, Postoperative

Criteria

5 inclusion criteria required to participate
ASA score I-III

Affiliated with a social security scheme

Aged 18 to 85 years

Having given their consent

Show More Criteria

14 exclusion criteria prevent from participating
Allergy or other cons-indication to the molecules used in the protocol

Drug addiction

Expected duration of surgery more than 3 hours

Minor or major protected patients

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this group receive a combination of Pregabaline (150mg) and Dexamethasone (20mg/5ml; 0.2mg/kg). The goal is to reduce postoperative pain after lumbar disc herniation surgery.

Group II

Placebo
Participants in this group receive a placebo, which is a substance that has no therapeutic effect. It's made of lactose (150mg) and a saline solution (50ml). This helps researchers compare the effects of the real treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHU Clermont-Ferrand

Clermont-Ferrand, FranceOpen CHU Clermont-Ferrand in Google Maps
CompletedOne Study Center