Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control

NCT05552391 | Completed Phase 4

• 1 other identifier: N-88-2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind randomized control study to compare the efficacy of dexmedetomidine versus ketamine as an adjuvant in combination with bupivacaine ultrasound-guided ESP block in patients scheduled for cardiothoracic surgeries with thoracotomy incision.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• the duration of analgesia

  the duration of analgesia from block start time (time of LA injection) to block end time at which OPS score 4 or more) was recorded.

  immediately at the end of pediatric cardiac operation

Study Arms (3)

bupivacaine

PLACEBO COMPARATOR

Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).

Drug: Bupivacaine

bupivacaine - ketamine

ACTIVE COMPARATOR

Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).

Drug: Bupivacaine; Drug: Ketamine Hydrochloride

bupivacaine - Dexametomedine

ACTIVE COMPARATOR

Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).

Drug: Bupivacaine; Drug: Dexmedetomidine Hydrochloride

Interventions

Bupivacaine DRUG

Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).

Also known as: Marcaine

bupivacaine; bupivacaine - Dexametomedine; bupivacaine - ketamine

Ketamine Hydrochloride DRUG

Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).

Also known as: Ketalar

bupivacaine - ketamine

Dexmedetomidine Hydrochloride DRUG

Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).

Also known as: Precedex

bupivacaine - Dexametomedine

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age from 3 to 36 months
• weight \>5 kg.
• gender both males and females
• cardiothoracic surgeries with thoracotomy incision.

You may not qualify if:

• Skin erosions , hematomas or infection at or near the injection site.
• \. coagulopathy,
• \. History of hypersensitivity to bupivacaine ,ketamine or dexametomedine.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and Pain managment

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 15, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

EG (1)