Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural

NCT06489574 | Completed

• 1 other identifier: MD-249-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To find out if there is a benefit from adding dexmedetomidine to epidural bupivacaine as regards:

• Intra and postoperative opioid consumption
• Pain score (numerical rating scale)
• Hemodynamic stability,
• Patient satisfaction.

Conditions

Post-operative Pain; Thoracic Epidural; Thoracotomy Surgery

Keywords

Thoracotomy; Dexmedetomidine; Thoracic Epidural; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups

  Dexmedetomidine compared to fentanyl as adjvant for thoracic epidural for post operative analgesia

  24 hours

Secondary Outcomes (8)

• Systolic arterial blood pressure in millimetre mercury

  Intraoperative

• heart rate (beat/ minute)

  Intraoperative

• Diastolic arterial blood pressure in millimetre mercury

  Intraoperative

• mean blood pressure n millimetre mercury

  Intraoperative

• Pain Score According to Numerical Rating Scale (NRS)

  24 Hours

Study Arms (2)

thoracic epidural with dexmedetomidine

EXPERIMENTAL

Patients will receive 50 μg dexmedetomidine with 10 ml of 0.125% bupivacaine followed by a continuous infusion of (10 ml bupivacaine + 25 μg dexmedetomidine + 39 ml saline with rate of 5 ml per hour)

Procedure: thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgery

thoracic epidural with fentanyl

EXPERIMENTAL

Patients will receive 50 μg fentanyl in addition to 10 ml 0.125% bupivacaine followed by a continuous infusion (10 ml bupivacaine + 100 μg fentanyl + 38 ml saline with rate of 5 ml per hour)

Procedure: thoracic epidural with fentanyl in patients undergoing thoracotomy surgery

Interventions

thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgery PROCEDURE

A thoracic epidural catheter will be inserted at the T6- T7 intervertebral space, with the patient in the sitting position with standard aseptic precautions using an 18-G Touhy needle via a midline or paramedian approach with a loss of resistance method. A test dose of 3 ml of 2% lignocaine with adrenaline 5 µ/ml will be administered. For thoracic surgery the sensory dermatome blockade needs to cover the incision and intercostal drains and may extend from T4 to T8. The epidural drug will be administered according to the group allocation over a period of 10 minutes as follows: Group A: Patients will receive 50 μg dexmedetomidine with 10 ml of 0.125% bupivacaine followed by a continuous infusion of (10 ml bupivacaine + 25 μg dexmedetomidine + 39 ml saline with rate of 5 ml per hour).

thoracic epidural with dexmedetomidine

thoracic epidural with fentanyl in patients undergoing thoracotomy surgery PROCEDURE

A thoracic epidural catheter will be inserted at the T6- T7 intervertebral space, with the patient in the sitting position with standard aseptic precautions using an 18-G Touhy needle via a midline or paramedian approach with a loss of resistance method. A test dose of 3 ml of 2% lignocaine with adrenaline 5 µ/ml will be administered. For thoracic surgery the sensory dermatome blockade needs to cover the incision and intercostal drains and may extend from T4 to T8. The epidural drug will be administered according to the group allocation over a period of 10 minutes as follows: Group B: Patients will receive 50 μg fentanyl in addition to 10 ml 0.125% bupivacaine followed by a continuous infusion (10 ml bupivacaine + 100 μg fentanyl + 38 ml saline with rate of 5 ml per hour).

thoracic epidural with fentanyl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 60 years old
• ASA physical status I-II-III
• Good mental function.
• Patient scheduled for thoracic surgery with posterolateral thoracotomy.
• BMI of patient (18 - 30).

You may not qualify if:

• Age less than 18 or more than 60 years old
• Any contraindications to epidural injection (patient refusal, local infection at the site of injection, coagulopathy, patients on anticoagulant or antiplatelet drugs, known allergy to local anesthetics, significant spine deformity)
• Inability to provide informed consent or pain score

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

Related Publications (8)

• Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.

  PMID: 21084984 BACKGROUND

• Salomaki TE, Laitinen JO, Nuutinen LS. A randomized double-blind comparison of epidural versus intravenous fentanyl infusion for analgesia after thoracotomy. Anesthesiology. 1991 Nov;75(5):790-5. doi: 10.1097/00000542-199111000-00010.

  PMID: 1952204 BACKGROUND

• Amr YM, Yousef AA, Alzeftawy AE, Messbah WI, Saber AM. Effect of preincisional epidural fentanyl and bupivacaine on postthoracotomy pain and pulmonary function. Ann Thorac Surg. 2010 Feb;89(2):381-5. doi: 10.1016/j.athoracsur.2009.10.060.

  PMID: 20103303 BACKGROUND

• Shaikh SI, Mahesh SB. The efficacy and safety of epidural dexmedetomidine and clonidine with bupivacaine in patients undergoing lower limb orthopedic surgeries. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):203-9. doi: 10.4103/0970-9185.182104.

  PMID: 27275050 BACKGROUND

• Sathyanarayana LA, Heggeri VM, Simha PP, Narasimaiah S, Narasimaiah M, Subbarao BK. Comparison of Epidural Bupivacaine, Levobupivacaine and Dexmedetomidine in Patients Undergoing Vascular Surgery. J Clin Diagn Res. 2016 Jan;10(1):UC13-7. doi: 10.7860/JCDR/2016/17344.7079. Epub 2016 Jan 1.

  PMID: 26894153 BACKGROUND

• Karhade SS, Acharya SA, Harnagale K. Comparative analysis of epidural bupivacaine versus bupivacaine with dexmedetomidine for vaginal hysterectomy. Anesth Essays Res. 2015 Sep-Dec;9(3):310-3. doi: 10.4103/0259-1162.158007.

  PMID: 26712965 BACKGROUND

• Bajwa SJ, Arora V, Kaur J, Singh A, Parmar SS. Comparative evaluation of dexmedetomidine and fentanyl for epidural analgesia in lower limb orthopedic surgeries. Saudi J Anaesth. 2011 Oct;5(4):365-70. doi: 10.4103/1658-354X.87264.

  PMID: 22144922 BACKGROUND

• Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.

  PMID: 27939192 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tea; Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• mohamed g soliman, MS

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized using a computer-generated list of random numbers, which will be sealed in closed envelopes. Patients will be randomly allocated to one of two groups; Group I will receive dexmedetomidine, while Group II (R) will receive fentanyl. An anesthesiologist who is not involved in the data collection team will perform all thoracic epidural infusion. Intra- and postoperative data will be collected by an anesthesiologist or intensivist who is blinded to the study protocol. So, both the patients and data collector were blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: July 8, 2024
• Study Start: January 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

EG (1)