Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain

NCT ID: NCT06331182

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2024-11-01

Brief Summary

The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

Detailed Description

Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.

As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.

Conditions

Dexmedetomidine; Ketamine; External Oblique Intercostal Plane Block; Post Thoracotomy Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ketamine group

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.

Bupivacaine

Intervention Type: DRUG

29 ml bupivacaine 0.25%

Dex group

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.

Bupivacaine

Intervention Type: DRUG

29 ml bupivacaine 0.25%

Interventions

Ketamine

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.

Intervention Type: DRUG

Dexmedetomidine

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.

Intervention Type: DRUG

Bupivacaine

29 ml bupivacaine 0.25%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-III.
• Scheduled for open thoracotomy.

Exclusion Criteria

• Patients with neurological or intellectual disability.
• Infection at the injection site.
• Opioid addiction.
• Allergic reaction to local anesthetics.
• Coagulation abnormalities.
• Drug abuse.
• Pregnancy.
• Severe liver and/or renal failure.
• Uncontrolled hypertension.
• Severe cardiovascular problems.
• Diabetes mellitus.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed S Elsharkawy, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, ElGharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR552/2/24

Identifier Type: -

Identifier Source: org_study_id