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

NCT06331182 | Completed

• 1 other identifier: 36264PR552/2/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to the 1st rescue analgesia

  A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.

  48 hours postoperative.

Secondary Outcomes (6)

• Intraoperative fentanyl consumption

  Intraoperative

• Total morphine consumption in the 1st 24hr and 48 hr

  48 hours postoperatively.

• Degree of pain

  48 hours postoperatively.

• Heart rate

  Till the end of surgery.

• Mean arterial blood

  Till the end of surgery.

Study Arms (2)

Ketamine group

EXPERIMENTAL

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

Drug: Ketamine; Drug: Bupivacaine

Dex group

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Bupivacaine

Interventions

Ketamine 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.

Ketamine group

Dexmedetomidine 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.

Dex group

Bupivacaine DRUG

29 ml bupivacaine 0.25%

Dex group; Ketamine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

Related Publications (1)

• Moharam SA, ElSharkawy MS, Abdelhamid AS, Abdelbadie A, Kohaf NA, El Rahman Elgaria MA, Attia A, Elkashef AM. Dexmedetomidine versus ketamine as adjuvants in external oblique intercostal plane block for post thoracotomy pain: a randomised trial. BMC Anesthesiol. 2025 Nov 26;25(1):602. doi: 10.1186/s12871-025-03476-2.

  PMID: 41299290 DERIVED

MeSH Terms

Interventions

Ketamine; Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Mohammed S Elsharkawy, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 26, 2024
• Study Start: March 26, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)