A Phase 3 interventional study of Sodium Chloride 0.9% and Dexamethasone in Knee Arthroscopy, sponsored by CMC Ambroise Paré. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by CMC Ambroise Paré · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Normal saline solution IV infusion
Drug: Sodium Chloride 0.9% · Drug: Chloroprocaine Injection [Clorotekal]
Dexamethasone IV infusion
Drug: Dexamethasone · Drug: Chloroprocaine Injection [Clorotekal]
IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes
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
Spinal anesthesia with chloroprocaine 40 mg
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.
Time frame: Up to 2 hours following spinal anesthesia
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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From spinal anesthesia to 24 hours after surgery
Incidence of bradycardia
Any episode of bradycardia defined as a heart rate (HR) \< 50 bpm
Time frame: From spinal anesthesia to 24 hours after surgery
Incidence of nausea
Any episode of nausea reported by the patient or nursing team
Time frame: From spinal anesthesia to 24 hours after surgery
Incidence of vomiting
Any episode of vomiting reported by the patient or nursing team
Time frame: From spinal anesthesia to 24 hours after surgery
Incidence of pruritus
Any episode of pruritus reported by the patient or nursing team
Time frame: From spinal anesthesia to 24 hours after surgery
Incidence of urinary retention
Any episode of urinary retention reported by the patient or nursing team
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: From spinal anesthesia to 24 hours after surgery
Duration of surgery
Time (in minutes) between the skin incision and the last suture
Time frame: Intraoperative period
Incidence of post-puncture headache
Any episode of headache reported by the patient or nursing team
Time frame: From spinal anesthesia to 24 hours after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CMC Ambroise Paré