Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy

• Sponsor: Ain Shams University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05850455
• Collaborator: (none)
• Enrollment: 78
• Arms: 3
• Anticipated Duration (Months): 6

Study Details

Study Description

Brief Summary

To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation	Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with; Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'; Procedure: General anesthesia; Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'	N/A

Detailed Description

Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A will receive local anesthesia with dexmedetomidine infusion	Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with; Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist; Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'; Lidocaine 1% which is a local analgesic as local infiltration
Experimental: Group B will receive epidural analgesia	Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'; The epidural insertion point will be 2 segments upper than the surgical procedure level, 10 ml of Bupivacaine 0.25% will be injected in the epidural space to adjust the sensory level
Experimental: Group Con will receive general anesthesia	Procedure: General anesthesia; Propofol 2-3 mg/kg'Diprivan 1%', Fentanyl 'Fentanyl' 2 μg/kg, and Cisatracurium 'Cisatracure' 0.2 mg/kg will be administered to facilitate endotracheal intubation, and ventilation will be controlled to maintain the end-tidal carbon dioxide (CO2) between 32-38 mmHg, to maintain anesthesia, 2-3% Sevoflurane 'Sevoflurane', and 0.05 mg/kg of the muscle relaxant Cisatracurium will be added at 40-minute intervals according to the conditions of the operation. No other medication will be administered

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible [4 hours]

   The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con

2. Heart rate [9 hours]

   Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours

3. Postoperative anesthetic complications [2 days]

   Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative

4. Satisfaction rate of anesthesia [1 hour]

   To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire

5. Systolic and Diastolic Blood pressure [9 hours]

   Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients American Society of anesthesiologists' physical status (ASA) I to II.

2. Aged 18 to 50 years.

3. Both sexes.

Exclusion Criteria:

• Spinal malformation

• Recurrent LDH

• Multi segment LDH

• Patients younger than 18 years or older than 50 years

• Patients with hypersensitivity to one of the used drugs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: riham fathy galal, Lecturer of Anesthesia, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05850455
• Other Study ID Numbers: FAMSU R 280/2022/2023
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Intervertebral Disc Displacement; Lidocaine; Dexmedetomidine; Bupivacaine

Study Results

No Results Posted as of May 9, 2023