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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505247-39-00 | EU Trial (CTIS) Number |
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Chloroprocaine is a short-acting local anesthetic that allows rapid recovery and early ambulation but is currently recommended for procedures lasting 40 minutes or less.
Dexamethasone is commonly used during anesthesia for the prevention of postoperative nausea and vomiting and has also been shown to prolong the duration of analgesia and sensory block after regional anesthesia.
Dexamethasone may therefore extend the duration of chloroprocaine spinal anesthesia, potentially allowing its use for longer surgical procedures while maintaining the benefits of rapid postoperative recovery.
This study aims to evaluate whether intravenous dexamethasone can prolong the effects of spinal anesthesia performed with chloroprocaine in adults undergoing knee arthroscopy.
This is a monocenter, prospective, randomized (1:1 ratio), controlled, parallel-group, double-blind, phase III superiority trial assessing the efficacy and the safety of IV dexamethasone for prolonging sensory block in patients undergoing knee arthroscopy under spinal anesthesia with chloroprocaine.
Participants will be randomly allocated into two groups:
To ensure blinding, study infusions (saline or dexamethasone) will be prepared in identical 100 mL bags and labelled by a pharmacy staff member or an "outside protocol" healthcare professional (physician or nurse) not involved in patient care or assessment.
The infusion will start approximately 10-15 minutes before the spinal punction.
In the operating room, patients will receive standard perioperative care for spinal anesthesia, including placement of a peripheral intravenous line, supplemental low-flow oxygen therapy to maintain SpO₂ > 93%, continuous hemodynamic monitoring, and strict aseptic precautions. Analgesic premedication with paracetamol combined with either ketoprofen or celecoxib will be administered according to institutional practice.
Spinal anesthesia will be performed with the patient in a semi-sitting position via the L3-L4 or L4-L5 interspace using a 25G x 80mm Sprotte needle. After cerebrospinal fluid reflux, 40 mg of chloroprocaine without adjuvant will be injected intrathecally, and patients will then be positioned in the supine position for the procedure.
Knee arthroscopy will be performed according to standard surgical practice, without any modification of the surgical procedure for study purposes.
No additional sedation or analgesia will be administered during the procedure. In the event of failure of spinal anesthesia or early recovery of sensation, conversion to general anesthesia or deep sedation may be performed at the discretion of the anesthesiologist, depending on the clinical situation.
Postoperatively, multimodal analgesia will be initiated according to the institutional protocol, combining paracetamol, nefopam, and either ketoprofen or celecoxib, with morphine administered if necessary.
Sensory and motor blocks will be assessed every 5 minutes after spinal puncture until regression of two dermatomes and then every 10 minutes until recovery of four dermatomes and complete motor function (maximum until hospital discharge).
Motor block will be assessed using the Bromage score and sensory block will be assessed using the Pin Prick test and the cold test.
The primary objective of the study is to evaluate the efficacy of intravenous dexamethasone in prolonging sensory block following spinal anesthesia with chloroprocaine, as assessed by the time from intrathecal injection to regression of sensory block by two dermatomes from the highest level of sensory block achieved, as measured by the pin-prick test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHLORO | Placebo Comparator | Normal saline solution IV infusion |
|
| CHLORODEX | Experimental | Dexamethasone IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Chloride 0.9% | Drug | IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to regression of sensory block by two dermatomes (pin-prick test) | Time (in minutes) from the spinal puncture to the first assessment at which the sensory block has regressed by two dermatomes from the maximum (highest/most cephalad) dermatome level of sensory block achieved after the puncture, assessed with the pin-prick test. Sensory testing will be performed every 5 minutes until two-dermatome regression is observed. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation. | Up to 2 hours following spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete resolution of motor block | Time (in minutes) from the spinal puncture to complete recovery of motor block, assessed by the Modified Bromage Scale (0-3: 0 = full flexion of hip, knee, and ankle; 1 = inability to raise extended leg; 2 = inability to flex knee; 3 = no movement of hip, knee, or ankle). Motor block will be assessed every 5 minutes after the spinal puncture until regression of the sensory block by two dermatomes, and then every 10 minutes until complete motor recovery (Bromage 0). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sébastien BLOC, MD | Contact | 01 44 14 11 11 | sebebloc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Drouot Rémusat | Paris | Île-de-France Region | 75016 | France |
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| Dexamethasone | Drug | IV infusion of dexamethasone at a dose of 0.15 mg/kg (maximum 16 mg), diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes |
|
| Chloroprocaine Injection [Clorotekal] | Drug | Spinal anesthesia with chloroprocaine 40 mg |
|
| Up to 8 hours following spinal anesthesia |
| Time to regression of sensory block by four dermatomes (pin-prick test) | Time (in minutes) from the spinal puncture to regression of four dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed using the pin-prick test every 5 minutes after the spinal puncture until regression by two dermatomes, and then every 10 minutes until regression by four dermatomes. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation. | Up to 8 hours following spinal anesthesia |
| Maximum sensory block level | Highest dermatome level of sensory block achieved after the spinal puncture (pin-prick test). | Up to 30 minutes following spinal anesthesia |
| Time to maximum sensory block level | Time (in minutes) from the spinal puncture to the highest blocked dermatome (pin-prick test). | Up to 30 minutes following spinal anesthesia |
| Need for additional anesthetic procedure | Whether an additional anesthetic procedure was required during surgery, including sedation or conversion to general anesthesia | From spinal anesthesia to the end of surgery |
| Time to regression of sensory block by two dermatomes (cold test) | Time (in minutes) from spinal puncture to two dermatome sensory regression assessed by a standardized cold test | Up to 2 hours following spinal anesthesia |
| Incidence of hypotension | Any episode of hypotension, defined as a systolic blood pressure (SBP) < 90 mmHg and/or a mean arterial pressure (MAP) < 65 mmHg and/or a decrease in blood pressure ≥ 30% from baseline | From spinal anesthesia to 24 hours after surgery |
| Incidence of bradycardia | Any episode of bradycardia defined as a heart rate (HR) < 50 bpm | From spinal anesthesia to 24 hours after surgery |
| Incidence of nausea | Any episode of nausea reported by the patient or nursing team | From spinal anesthesia to 24 hours after surgery |
| Incidence of vomiting | Any episode of vomiting reported by the patient or nursing team | From spinal anesthesia to 24 hours after surgery |
| Incidence of pruritus | Any episode of pruritus reported by the patient or nursing team | From spinal anesthesia to 24 hours after surgery |
| Incidence of urinary retention | Any episode of urinary retention reported by the patient or nursing team | From spinal anesthesia to 24 hours after surgery |
| Maximal pain score in the PACU | Maximal pain score collected in the PACU using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain). | Up to 6 hours following spinal anesthesia |
| Total opioid consumption | Total opioid consumption, converted to oral morphine equivalents (OME, mg) from the intraoperative period to 24 hours postoperatively, including opioid use at home as reported during the Day 1 follow-up | From spinal anesthesia to 24 hours after surgery |
| Pain intensity | Pain intensity at rest and during movement will be assessed using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain). Pain scores will be recorded intraoperatively (H0)in the PACU (H1), during ambulatory hospitalization (H3 and H6), and at home until Day-1 (H9, H12 and H24). | From spinal anesthesia to 24 hours after surgery |
| Duration of surgery | Time (in minutes) between the skin incision and the last suture | Intraoperative period |
| Incidence of post-puncture headache | Any episode of headache reported by the patient or nursing team | From spinal anesthesia to 24 hours after surgery |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| C004616 | chloroprocaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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