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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078062
• Other study ID #: 16.374
• Status: Completed
• Phase: N/A
• First received: March 3, 2017
• Last updated: October 26, 2017
• Start date: May 26, 2017
• Est. completion date: October 26, 2017

Study information

• Verified date: October 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Motor Block
• Prolonged Sensory Block
• Spinal Anesthesia

Intervention

Drug:
• Dexamethasone
Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia
• Normal saline
Administration of a single-dose of Normal saline during spinal anesthesia

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression of sensory block by 2 dermatomes	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	At regression of spinal anesthesia by 2 dermatomes, approximately 2 hours after surgery
Secondary	Duration of motor block	Using the Bromage scale from the time of injection of bupivacaine for spinal anesthesia until complete recovery of motor block	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
Secondary	Onset of sensory block	Time from injection of bupivacaine for spinal anesthesia to reduction of sensitivity using loss of pinprick sensation	Up to 30 minutes following spinal anesthesia
Secondary	Onset of motor block	Time from injection of bupivacaine for spinal anesthesia to reduction of lower limbs movement using the Bromage scale	Up to 30 minutes following spinal anesthesia
Secondary	Quality of motor block	Maximal Bromage score	Up to 30 minutes following spinal anesthesia
Secondary	Surgeon's satisfaction towards spinal anesthesia	Unsatisfied or satisfied	At the end of surgery, on the day of randomization
Secondary	Time to first analgesic request	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"	From the end of surgery up to approximately six hours after surgery, on the day of randomization
Secondary	Opioid consumption	Total dose of opioids	At recovery room discharge, approximately one hour after the end of surgery on the day of randomization and 24 hours following surgery
Secondary	Incidence of hypotension	Systolic blood pressure lower than 90 mm Hg	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Incidence of bradycardia	Heart rate slower than 50 beats per minute	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Incidence of nausea	Any episode of nausea reported by the patient or nursing team	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Incidence of vomiting	Any episode of retching or vomiting reported by the patient or nursing team	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Incidence of urinary retention	Any episode of urinary retention reported by the patient or nursing team	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Incidence of shivering	Any episode of shivering reported by the patient or nursing team	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Incidence of headache	Any episode of headache reported by the patient or nursing team	From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Secondary	Quality of sleep	Described by the patient as good or bad	At 24 hours after surgery
Secondary	Duration of sensory block	Loss of pinprick sensation by Von Frey filaments from the injection of bupivacaine for spinal anesthesia until complete recovery	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