Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479216
• Other study ID #: U1111-1211-1791
• Status: Completed
• Phase: Phase 4
• Start date: March 26, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2018
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Arthroscopic meniscus surgeries are the most frequent orthopedic procedures. The objective of the study is to compare the effects of intraarticular local anesthetic and adjuvant (dexmedetomidine vs magnesium) combinations in postoperative pain and analgesic requirement. The investigators' hypothesis is adjuvants added to the local anesthetics decreases the total local anesthetic dose, provides more effective pain relief according to local anesthetic only, and decreases the postoperative systemic non-steroidal analgesic and opioid doses.

Description:

Arthroscopic meniscus surgeries are the most frequent orthopedic procedures. However, irritation of free nerve endings in the synovial tissue and anterior fat pads and stretching and resection in the joint capsule lead to pain at various levels. Proper pain management enhances recovery, provides early mobilization and shortens length of hospital stay.

"Opioid-free" analgesia methods are frequently emphasized in published postoperative pain management guidelines and multimodal treatment approaches such as local anesthetic infiltration is recommended. In the treatment of knee pain, intra-articular drug injections are the most commonly used method because of minimal systemic side effects.

The drugs most commonly administered intraarticularly included local anesthetics (bupivacaine, levobupivacaine, lidocaine), opioids (morphine, fentanyl), magnesium sulfate, steroids, and α2 agonists (clonidine, dexmedetomidine).

Dexmedetomidine is a selective, specific, lipophilic and potent α2 adrenergic receptor agonist with sedative, anxiolytic, analgesic, antihypertensive and sympatholytic effects. It provides analgesic activity through both the central and peripheral nervous system. The analgesic effects of intra-articular administration of dexmedetomidine in arthroscopic surgeries have been demonstrated. Most side effects of this drug included hypotension and bradycardia. However, these side effects have never been encountered with intra-articular injection of the drug.

Magnesium is also an adjuvant drug which has a key role in nociceptive transmission, and acts as a NMDA (N-Methyl-D-Aspartate) antagonist in spinal neurons.

While opioid free anesthesia and analgesia methods gain importance nowadays, there has been increased interest in non-opioid analgesic drugs and multimodal analgesia applications. In order to increase the effects of local anesthetics and prolong their analgesic times, the addition of various adjuvants to local anesthetics is frequently used.

In the randomized controlled trials, intraarticular local anesthetic drugs combined with adjuvant drugs for postoperative analgesia were found to be superior to local anesthetic drugs alone. It is also known that local anesthetics have negative effects on chondrocytes. One of the goals of the investigators' in this study is to reduce the amount of local anesthetic used by adding adjuvant to local anesthetics.

In this study, the investigators plan to compare the efficacy of 2 adjuvants (magnesium sulfate and dexmedetomidine) combined with local anesthetics to be given intraarticularly for postoperative pain management after elective arthroscopic surgery.

Intraarticular high-volume drug injections may cause pain due to tension in the joint capsule. Additionally, the investigators aim to decrease the total drug volume with adjuvant drugs used in combination with local anesthetic, and thus to prevent joint capsule tension pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age >18, <65

• scheduled for elective knee arthroscopy under spinal anesthesia

• ASA I and ASA II

Exclusion Criteria:

• age <18 and >65

• patients who received general anesthesia

• diabetes

• refusal of the patient

• known allergy to the specified drugs

Related Conditions & MeSH terms

• Dexmedetomidine
• Intra-articular Injection
• Magnesium Sulfate
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Precedex
10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.
• Magnesium Sulfate
10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.

Locations

Country	Name	City	State
Turkey	Derince Training and Research Hospital	Kocaeli	Derince

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Alipour M, Tabari M, Faz RF, Makhmalbaf H, Salehi M, Moosavitekye SM. Effect of dexmedetomidine on postoperative pain in knee arthroscopic surgery; a randomized controlled clinical trial. Arch Bone Jt Surg. 2014 Mar;2(1):52-6. Epub 2014 Mar 15. — View Citation

Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. Epub 2007 Feb 13. Review. Erratum in: Ann Pharmacother. 2007 Mar;41(3):530-1. — View Citation

Heydari SM, Hashemi SJ, Pourali S. The Comparison of Preventive Analgesic Effects of Ketamine, Paracetamol and Magnesium Sulfate on Postoperative Pain Control in Patients Undergoing Lower Limb Surgery: A Randomized Clinical Trial. Adv Biomed Res. 2017 Oct — View Citation

Kizilcik N, Özler T, Menda F, Uluçay Ç, Köner Ö, Altintas F. The effects of intra-articular levobupivacain versus levobupivacain plus magnesium sulfate on postoperative analgesia in patients undergoing arthroscopic meniscectomy: A prospective randomized c — View Citation

Li C, Qu J. Efficacy of dexmedetomidine for pain management in knee arthroscopy: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Oct;96(43):e7938. doi: 10.1097/MD.0000000000007938. Review. — View Citation

Sun R, Zhao W, Hao Q, Tian H, Tian J, Li L, Jia W, Yang K. Intra-articular clonidine for post-operative analgesia following arthroscopic knee surgery: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2014 Sep;22(9):2076-84. doi: — View Citation

Yang Y, Zeng C, Wei J, Li H, Yang T, Deng ZH, Li YS, Yang TB, Lei GH. Single-dose intra-articular bupivacaine plus morphine versus bupivacaine alone after arthroscopic knee surgery: a meta-analysis of randomized controlled trials. Knee Surg Sports Traumat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	postoperative pain scores (rest and movement) (ward) Pain scores were assessed with a 10-cm Visual Analogue Scale (VAS) (with 0 = no pain and 10 = the worst imaginable pain)	24 hours
Secondary	Postoperative Opioid/NSAID Consumption	nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.	24 hours
Secondary	Rescue Analgesic Time	Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)	24 hours
Secondary	Surgery Time	time from skin incision to closure	24 hours
Secondary	Time to the End of Spinal Anesthesia	time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)	24 hours
Secondary	Mobilization	First mobilization time after surgery	24 hours
Secondary	Number of Participants With Complications Due to Intraarticular Injection	post-injection complications due to intraarticular injection will be noted.	24 hours