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Completed

NCT Number: NCT03078062

Impact of Dexamethasone on the Duration of Sensory and Motor Block Following Spinal Anesthesia

The purpose of this study is to assess the effect of a single-dose of intravenous dexamethasone 8 mg on the duration of sensory and motor blockade following spinal anesthesia with isobaric bupivacaine.

The hypothesis of the study is that intravenous dexamethasone will significantly prolong (by more than 20 minutes) the duration of spinal anesthesia.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

About this study

Spinal anesthesia is commonly used for lower body surgery. The injection of local anesthetics in the lumbar intrathecal space allows the desensitization of the lower body by blocking sensory and motor nerve roots. In return, spinal anesthesia causes a sympathetic block which is associated with deleterious hemodynamic effects such as hypotension.

Using intravenous or intrathecal adjuvants to local anesthetics may prolong the duration of sensory and motor blockade following spinal anesthesia. Various intrathecal additives have been studied such as opioids, adrenalin, clonidine, dexmedetomidine, midazolam, ketamine, magnesium, ketorolac and neostigmine. Most of them failed to prolong the duration of spinal anesthesia and side-effects have restricted their use.

Dexamethasone is a potent corticosteroid with a half-life of 36 to 72 hours and an onset of action of 1 to 2 hours. The safety of single doses of intravenous dexamethasone is well documented. Dexamethasone is widely used in anesthesia to prevent nausea and vomiting and treat post-extubation sore throat and postoperative shivering. It is also increasingly used in orthopaedic surgery to reduce opioid needs without increasing the risks of infection, wound dehiscence and osteonecrosis. The use of dexamethasone in the perioperative period reduces postoperative edema allowing early mobilization and improved functional recovery.

Recent studies have demonstrated that both perineural and intrathecal administration of dexamethasone can prolong the duration of peripheral and spinal anesthesia. However, dexamethasone has not been approved by health authorities for these indications and thus, the safety of this practice remains controversial. A recent study has compared peripheral to intravenous administration of dexamethasone for interscalene blocks. This study demonstrated the equivalency of these regimens in increasing the analgesic duration of a single-shot interscalene block.

The impact of intravenous dexamethasone on the duration of spinal anesthesia remains unknown. This study will investigate the effect of a single-dose of dexamethasone 8 mg on the duration of the sensory and motor block following spinal anesthesia.

Sixty patients scheduled for lower body surgery under spinal anesthesia will be considered for this study.

After placement of standard non-invasive monitoring, spinal anesthesia will be performed in the sitting position using a 25 gauge (GA) pencil point needle (Whitacre, Pencan). After aspiration of cerebrospinal fluid (CSF), a dose of isobaric 0.5% bupivacaine 12 mg will be injected. The aspiration of CSF will be repeated at the end of the injection. While performing spinal anesthesia, an intravenous infusion of dexamethasone 8 mg or placebo will be initiated according to randomization.

Subsequently, the patient will be placed in supine position. Sensory block will be measured by loss of sensation to pinprick at 5, 10, 20 and 30 minutes following spinal anesthesia and then every 15 minutes until confirmation of regression by two dermatomes. Loss of sensation will be assessed every 30 minutes thereafter. Motor block will be assessed using the Bromage scale at the same frequency until full recovery.

Sedation will be allowed during the performance of the spinal anesthesia technique and surgery. In case of unsatisfactory quality of spinal anesthesia, general anesthesia will be performed.

At the end of surgery, patients will be transferred to the recovery room. Multimodal analgesia including celecoxib and acetaminophen will be administered. Pain will be assessed using a verbal numeric pain scale (VNPS) of 0 to 10, where 0 means "No pain" and 10 means "Worst pain imaginable". Intravenous hydromorphone will be administered when VNPS is superior to 3. Postoperative nausea and vomiting will be managed with intravenous ondansetron, dimenhydrinate and haloperidol.

Opioid intake, presence of side-effects and quality of sleep will be assessed during the first 24 hours following surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing lower body surgery under spinal anesthesia
  • American Society of Anesthesiologists' physical status of 1 to 3

Exclusion criteria

  • Contraindication to spinal anesthesia (coagulopathy, local infection at the site of injection)
  • Pre-existing neuropathy or nerve block that could compromise study assessments
  • Preoperative use of systemic corticosteroids
  • Allergy or hypersensitivity to local anesthetics, dexamethasone or other drugs used in this study
  • Patient refusal or inability to consent

Treatment and study plan

Dexamethasone

Drug

Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia

Other names: Decadron

normal saline

Drug

Administration of a single-dose of Normal saline during spinal anesthesia

Other names: Placebo

Primary outcomes

  1. Regression of sensory block by 2 dermatomes

    Time frame: At regression of spinal anesthesia by 2 dermatomes, approximately 2 hours after surgery

    Loss of pinprick sensation by Von Frey filaments from the injection of bupivacaine for spinal anesthesia until regression of the sensory block by two dermatomes from the peak sensory level

Secondary outcomes

  1. Duration of motor block

    Time frame: At 5,10, 20 and 30 minutes following spinal anesthesia, then every 15 minutes until regression of 2 dermatomes and every 30 minutes thereafter until complete recovery, approximately 4 hours after surgery

    Using the Bromage scale from the time of injection of bupivacaine for spinal anesthesia until complete recovery of motor block

  2. Onset of sensory block

    Time frame: Up to 30 minutes following spinal anesthesia

    Time from injection of bupivacaine for spinal anesthesia to reduction of sensitivity using loss of pinprick sensation

  3. Onset of motor block

    Time frame: Up to 30 minutes following spinal anesthesia

    Time from injection of bupivacaine for spinal anesthesia to reduction of lower limbs movement using the Bromage scale

  4. Quality of motor block

    Time frame: Up to 30 minutes following spinal anesthesia

    Maximal Bromage score

  5. Surgeon's satisfaction towards spinal anesthesia

    Time frame: At the end of surgery, on the day of randomization

    Unsatisfied or satisfied

  6. Time to first analgesic request

    Time frame: From the end of surgery up to approximately six hours after surgery, on the day of randomization

    First request by the patient for an analgesic or pain superior to 3 on a scale from 0 to 10; where 0 means "no pain at all" and 10 means "worst pain imaginable"

  7. Opioid consumption

    Time frame: At recovery room discharge, approximately one hour after the end of surgery on the day of randomization and 24 hours following surgery

    Total dose of opioids

  8. Incidence of hypotension

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Systolic blood pressure lower than 90 mm Hg

  9. Incidence of bradycardia

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Heart rate slower than 50 beats per minute

  10. Incidence of nausea

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Any episode of nausea reported by the patient or nursing team

  11. Incidence of vomiting

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Any episode of retching or vomiting reported by the patient or nursing team

  12. Incidence of urinary retention

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Any episode of urinary retention reported by the patient or nursing team

  13. Incidence of shivering

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Any episode of shivering reported by the patient or nursing team

  14. Incidence of headache

    Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery

    Any episode of headache reported by the patient or nursing team

  15. Quality of sleep

    Time frame: At 24 hours after surgery

    Described by the patient as good or bad

  16. Duration of sensory block

    Time frame: At 5,10, 20 and 30 minutes following spinal anesthesia, then every 15 minutes until regression by 2 dermatomes and every 30 minutes thereafter until complete recovery, approximately 4 hours after surgery

    Loss of pinprick sensation by Von Frey filaments from the injection of bupivacaine for spinal anesthesia until complete recovery

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Impact of Intravenous Dexamethasone on the Duration of Sensory and Motor Block Following a Bupivacaine-based Spinal Anesthesia

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2017
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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