Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia

Lower Limb Surgery Clinical Trial

Official title:

Optimal Single-dose Intrathecal Dexmedetomidine for Postoperative Analgesia After Lower Limb Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02660658
• Other study ID #: R / 16.01.15
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2016
• Last updated: February 24, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2017
• Source: Mansoura University
• Contact: Samah Elkenany, MD
• Phone: 00201002262557
• Email: sk_20022000[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal anesthesia is a commonly used technique for lower limb surgeries offering better quality of postoperative analgesia, lower incidence of side effects, and shorter post-anesthesia care unit stay than general anesthesia. However, the relatively short duration of action of the currently available local anesthetics (LAs) make these advantages short-lived.

The risk for local anesthetic toxicity (LAST) increases with the trials to use higher concentrations or volumes of intrathecal local anesthetics to increase the duration of analgesia.

Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without the need for using high doses of local anesthetics and hence with decreasing the potential risk of local anesthetic, but the increased likelihood adverse effects such as short term bradycardia and prolonged duration of motor block may offset these benefits.

Description:

The aim of this study is to determine the optimal single-dose of intrathecal dexmedetomidine that prolongs the analgesic duration with the least possible side effects.

With the patients in the sitting position and the use of complete aseptic technique, 25G Whitacre spinal needles will be introduced through L2-L4 interspaces and after observing free flow of the CSF, a 3ml volume including bupivacaine 12.5mg in conjunction with dexmedetomidine (3 µg) will be injected in the first case, then the patient will be turned supine.

The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical class I to II.

• Patients scheduled for elective lower limb surgeries.

Exclusion Criteria:

• Morbid obese patients.

• Severe or uncompensated cardiovascular disease.

• Significant renal disease.

• Significant hepatic disease.

• Pregnancy.

• Lactating .

• Heart block.

• Bradyarrhythmias.

• Receiving adrenergic receptor antagonist medications.

• Receiving calcium channel blockers.

• Patients with pacemakers.

• Patients with implanted cardioverter defibrillator.

• Allergy to the study medications.

• Psychological disease.

• Neurological disorders.

• Communication barrier.

• Mental disorders.

• Epilepsy.

• Drug or alcohol abuse.

• Contraindications to spinal anaesthesia.

• Receiving opioid analgesic medications within 24 h before the operation.

Related Conditions & MeSH terms

• Lower Limb Surgery

Intervention

Drug:
• Intrathecal dexmedetomidine
The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of analgesia	The duration of analgesia, defined as the time from administering of intrathecal study solution (T0) to the time for the first rescue analgesic request	For 13 hours after surgery
Secondary	Postoperative pain score	Using visual analog scale	For 24 hours after surgery
Secondary	Onset of sensory blockade	Onset of sensory block time defined as the time elapsed from T0 to achieve the adequate sensory level for the planned surgery.	For 1 hour after initiaion of spinal anesthesia
Secondary	Onset of motor blockade	Onset of motor block time defined as the time elapsed from T0 to achieve the Bromage scale of 3	For 2 hours after initiation of spinal anesthesia
Secondary	Highest dermatome level of sensory blockade	The highest dermatome level of sensory blockade and the time needed to achieve this level from the time of injection as well as time to two segment sensory regression after T0 will be recorded	For 4 hours after initiation of spinal anesthesia
Secondary	Time to motor regression	Time to motor regression to a Bromage scale of 2	For 6 hours after initiation of spinal anesthesia
Secondary	Sedation score	Sedation scores will be assessed using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep sleep= 3).	For 24 hours after initiation of spinal anesthesia
Secondary	Postoperative nausea and vomiting	The degree of nausea and vomiting. Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3)	For 24 hours after initiation of spinal anesthesia
Secondary	Cumulative tramadol consumption		For 24 hours after surgery
Secondary	Intraoperative bradycardia		For 4 hours after initiation of spinal anesthesia
Secondary	Intraoperative use of ephedrine		For 4 hours after initiation of spinal anesthesia
Secondary	Intraoperative use of atropine		For 4 hours after initiation of spinal anesthesia
Secondary	Intraoperative use of supplemental fentanyl		For 4 hours after initiation of spinal anesthesia
Secondary	Intraoperative use of midazolam		For 4 hours after initiation of spinal anesthesia