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

NCT ID: NCT05552391

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-04-15

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

bupivacaine

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

Group Type: PLACEBO_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

bupivacaine - ketamine

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 Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Ketamine Hydrochloride

Intervention Type: 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).

bupivacaine - Dexametomedine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Dexmedetomidine Hydrochloride

Intervention Type: 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).

Interventions

Bupivacaine

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

Intervention Type: DRUG

Ketamine Hydrochloride

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

Dexmedetomidine Hydrochloride

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

Other Intervention Names

Marcaine; Ketalar; Precedex

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Mohamed Elhaddad

Lecturer of Anesthesia, ICU and Pain managment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasralainy Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-88-2022

Identifier Type: -

Identifier Source: org_study_id