Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

Intrathecal Dexmedetomidine Versus Midazolam as Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia in High Tibial Osteotomy. A Randomized, Prospective, Double- Blinded, Comparative Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082232
• Other study ID #: Postoperative analgesia in HTO
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Ahmed Farghali
• Phone: +201068914686
• Email: ahmedsayedali2016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the postoperative analgesic effect of intrathecal dexmedetomidine combined with bupivacaine and midazolam combined with bupivacaine in high tibial osteotomy.

Description:

With more than 80% of patients experiencing acute pain following surgical procedures, and half of them reporting inadequate pain therapy, the control and management of post-surgical pain remains one of the most challenging aims of modern anesthesia.

Adequate postoperative pain control is an important part of postoperative care treatment. World Health Organization, as well as International Association for the Study of Pain, have emphasized its significance for patients well-being, and determined pain relief to be a human right and the occurrence of pain as fifth vital sign.

Local anesthetic, bupivacaine, is the most common agent used for spinal anesthesia but has relatively short duration of action. Many adjuvants to local anesthetics have been used intrathecally to improve the quality of intraoperative analgesia and prolong it in the postoperative period.

Diverse classes of drugs such as opioids , epinephrine , neostigmine , magnesium , midazolam , ketamine , and clonidine have been added to intrathecal local anaesthetics in an attempt to prolong analgesia and reduce the incidence of adverse events.

Opioids are commonly added to local anaesthetics to produce spinal and epidural anesthesia. However, significant adverse effects such as, urinary retention, respiratory depression, hemodynamic instability, pruritus and occasionally severe nausea and vomiting, may limit their use .

α2-adrenergic agonists are new neuraxial adjuvants being studied to improve the quality of subarachnoid blockade regarding both sensory and motor blockades. There are many studies supporting their efficacy as adjuvants individually.

Dexmedetomidine, a highly specific, potent, and selective α2-adrenergic agonist, provides stable hemodynamic conditions and good quality of intraoperative and prolonged postoperative analgesia with minimal side effects.

Discovery of benzodiazepine receptors in spinal cord in 1977 triggered the use of intrathecal midazolam for prolongation of spinal anesthesia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult patients aged 18-60 years.

• Gender: Both males and females.

• Scheduled patients for High tibial osteotomy under spinal anesthesia.

• American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria:

• Patient refusal

• Allergy to the studied drugs.

• Patients with contraindications to spinal anesthesia.

• Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases

• Coagulopathy or thrombocytopenia

• CNS diseases as epilepsy, stroke or psychiatric illness.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
Under strict aseptic conditions, a lumbar puncture will be performed with selective technique in sitting position at L2-3 or L3-4 interspaces with midline approach using a 25-G Quincke's needle. After achieving the free flow of cerebrospinal fluid, the study drug will be injected into the subarachnoid space, immediately after injection the patient will be asked for supine position.
• Midazolam
1 mg midazolam intrathecal administration
• Bupivacain
20 mg bupivacaine intrathecal administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55. — View Citation

Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037. — View Citation

Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x. — View Citation

Mohler H, Okada T. Benzodiazepine receptor: demonstration in the central nervous system. Science. 1977 Nov 25;198(4319):849-51. doi: 10.1126/science.918669. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic request	Time to first analgesic request calculated from the administration of local anesthetic	24 hours
Secondary	analgesic consumption	Total analgesic consumption in the first 24 hour .	24 hours
Secondary	Incidence of complications	Incidence of complications (bradycardia , hypotension ,nausea and vomiting).	24 hours