Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine
Ketamine Hydrochloride
Dexmedetomidine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- age from 3 to 36 months
- weight >5 kg.
- gender both males and females
- cardiothoracic surgeries with thoracotomy incision.
Exclusion Criteria:
- 1 Skin erosions , hematomas or infection at or near the injection site.
- 2. coagulopathy,
- 3. History of hypersensitivity to bupivacaine ,ketamine or dexametomedine.
Sites / Locations
- Kasralainy Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
bupivacaine
bupivacaine - ketamine
bupivacaine - Dexametomedine
Arm Description
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05552391
First Posted
September 20, 2022
Last Updated
September 23, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05552391
Brief Title
Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control
Official Title
Dexametomedine Versus Ketamine as an Adjuvant in Ultrasound Guided Erector Spinae Block for Perioperative Thoracotomy Pain Control in Pediatrics Cardiothoracic Surgeries: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Following approval from research and ethics committee ,preoperative preparation, and induction of anesthesia Patients will be allocated to three groups according to the type of drug injected.
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
Unilateral Ultrasound-guided erector spinae block will be applied in both groups after the induction of anaesthesia. All patients will be tilted onto their left side (lateral position). while the ultrasound-guide unilateral erector spinae block will be performed under completely aseptic conditions. The anatomy will be examined by ultrasonography at 5-6Hz with a35 mm linear probe and a SonoSite M-turbo system (Fujifilm SonoSite, Inc., USA). a 22 g bevel needle will be advanced in a cephalad to caudad direction until the tip of the needle reach' the plane deep to the erector spinae muscle and immediately lateral to the transverse process. Once confirmed, after careful aspiration to demonstrate the absence of air or blood. An injection in this plane permitted the block to impact both the dorsal and ventral rami as they exited from the thoracic spine to innervate the chest wall. the block permits a diminished sensation spanning the T3-T10 dermatome levels. confirming the correct tissue plane by hydro-dissection.
Heart rate, mean arterial pressure, and oxygen saturation will be monitored continuously.
After completion of the surgery, inhalational anesthetics will be stopped as well the muscle relaxant. The patient will be then transferred to the ICU.
Postoperative assessment and analgesic regimen:
Post-operative pain intensity will be assessed using the objective pain score (OPS) by a person who will be blinded to the treatment. OPS score will be recorded at baseline,3,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. for the score 4 or more, which was considered the end point of the study, and at this point. Patients will receiv paracetamol 15 gm / Kg IV /6 h, as components of multimodal analgesia regimen for postoperative pain control.
Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.1mg/kg to maintain resting (OPS) score ˂ 4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bupivacaine
Arm Type
Placebo Comparator
Arm Description
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Arm Title
bupivacaine - ketamine
Arm Type
Active Comparator
Arm Description
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Arm Title
bupivacaine - Dexametomedine
Arm Type
Active Comparator
Arm Description
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
Ketalar
Intervention Description
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Other Intervention Name(s)
Precedex
Intervention Description
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
Primary Outcome Measure Information:
Title
the duration of analgesia
Description
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.
Time Frame
immediately at the end of pediatric cardiac operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age from 3 to 36 months
weight >5 kg.
gender both males and females
cardiothoracic surgeries with thoracotomy incision.
Exclusion Criteria:
1 Skin erosions , hematomas or infection at or near the injection site.
2. coagulopathy,
3. History of hypersensitivity to bupivacaine ,ketamine or dexametomedine.
Facility Information:
Facility Name
Kasralainy Faculty of Medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Elhaddad, MD
Phone
01224042847
Email
drblacksmith5@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control
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