Knee Arthroscopy
Conditions
Keywords
Knee arthroscopy, dexamethasone, chloroprocaine, spinal anesthesia, sensory block, motor block
Brief summary
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.
Detailed description
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: * Group CHLORO (control group): Patients will receive spinal anesthesia with chloroprocaine 40mg (Clorotekal®10 mg/mL, solution for injection, 4 mL) combined with an IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes. * Group CHLORODEX (experimental group): Patients will receive spinal anesthesia with chloroprocaine 40 mg (Clorotekal®10 mg/mL, solution for injection, 4 mL) combined with an 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. 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.
Interventions
DRUGSodium Chloride 0.9%
IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes
DRUGDexamethasone
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
Sponsors
CMC Ambroise Paré
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery), * Signed written informed consent form, * Affiliation to a social security system, * Negative pregnancy test on the day of procedure for non-menopausal patients.
Exclusion criteria
* Contraindications to spinal anesthesia with intrathecal chloroprocaine * History of diabetes, * Pre-existing peripheral neuropathy, * American Society of Anesthesiologists (ASA) physical status IV, * Contraindication to dexamethasone, * Hypersensitivity of any drug used in this study, * Long-term oral corticosteroid therapy, * Chronic opioid use, * Chronic pain syndromes, * Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib) * Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty), * Mental or linguistic inability to understand the study, * Patients under legal protection (guardianship, curatorship or safeguard of justice), * Patients currently included or planning to be included in another interventional study, * Pregnant or breastfeeding women, * Women of childbearing potential not using effective contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to regression of sensory block by two dermatomes (pin-prick test) | Up to 2 hours following spinal anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete resolution of motor block | Up to 8 hours following spinal anesthesia | 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 to regression of sensory block by four dermatomes (pin-prick test) | Up to 8 hours following spinal anesthesia | 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. |
| Maximum sensory block level | Up to 30 minutes following spinal anesthesia | Highest dermatome level of sensory block achieved after the spinal puncture (pin-prick test). |
| Time to maximum sensory block level | Up to 30 minutes following spinal anesthesia | Time (in minutes) from the spinal puncture to the highest blocked dermatome (pin-prick test). |
| Need for additional anesthetic procedure | From spinal anesthesia to the end of surgery | Whether an additional anesthetic procedure was required during surgery, including sedation or conversion to general anesthesia |
| Time to regression of sensory block by two dermatomes (cold test) | Up to 2 hours following spinal anesthesia | Time (in minutes) from spinal puncture to two dermatome sensory regression assessed by a standardized cold test |
| Incidence of hypotension | From spinal anesthesia to 24 hours after surgery | 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 |
| Incidence of bradycardia | From spinal anesthesia to 24 hours after surgery | Any episode of bradycardia defined as a heart rate (HR) \< 50 bpm |
| Incidence of nausea | From spinal anesthesia to 24 hours after surgery | Any episode of nausea reported by the patient or nursing team |
| Incidence of vomiting | From spinal anesthesia to 24 hours after surgery | Any episode of vomiting reported by the patient or nursing team |
| Incidence of pruritus | From spinal anesthesia to 24 hours after surgery | Any episode of pruritus reported by the patient or nursing team |
| Incidence of urinary retention | From spinal anesthesia to 24 hours after surgery | Any episode of urinary retention reported by the patient or nursing team |
| Maximal pain score in the PACU | Up to 6 hours following spinal anesthesia | 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). |
| Total opioid consumption | From spinal anesthesia to 24 hours after surgery | 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 |
| Pain intensity | From spinal anesthesia to 24 hours after surgery | 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). |
| Duration of surgery | Intraoperative period | Time (in minutes) between the skin incision and the last suture |
| Incidence of post-puncture headache | From spinal anesthesia to 24 hours after surgery | Any episode of headache reported by the patient or nursing team |
Countries
France
Contacts
CONTACTSébastien BLOC, MD
Outcome results
None listed