Aalgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery

Phase 1

• Conditions: Erector Spinae Block Analgesia
• Interventions: Drug: Levobupivacaine

• Registration Number: NCT04315454
• Lead Sponsor: South Egypt Cancer Institute

Brief Summary

To study analgesic efficacy \&safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia.

Detailed Description

Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, each group of the them consist of 15 patients:

GROUP (A): {CONTROL GROUP} Patient will receive 20 ml of normal saline into interfascial plane between rhomboidus major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side .

Group (B):

Patient will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.

Preoperatively \& post-operatively procedures:

Premedication will be given after complete fasting hours \&after applying standard monitors (non invasive blood pressure, pulse oximetery, ECG, temperature and capnography, an intra-venous 16 gauge cannula will be inserted and secured).

Ultrasound guided Erector spinae plane block with patient in the sitting position \& skin of the upper back is prepared with 2% chlorhexidine solution. Counting down from c7,the spine of T7 is identified it is corresponding to the tip the scapular spine ,a high frequency ultrasound probe is placed across T7 spine then probe move slowly laterally to identify transverse process of T7 ,So probe is moved to a vertical alignment and erector spinae muscle is visualized lying underneath the trapezius muscle.

Needle gauge will be inserted then 10 ml Levobupivacaine into interfascial plane between rhomboid major \& erector spinae muscle in each side.

General anesthesia will be induced with Fentanyl 0.5 μg/kg, Propofol 2mg/kg, muscle relaxant (Atracurium 0.5 mg /kg) , inhalational anesthesia ( Isoflurane 1-1.5 MAC-or-sevoflurane2-3MAC ) as maintenance of anesthesia with frequent muscle relaxant every 20 minutes to maintain heart rate (HR) and blood pressure within 20% of the basal value. Patients were mechanically ventilated to maintain end tidal (ETCO2) between 35-40 mmHg. The inspired oxygen fraction (FIO2) was 0.5 using oxygen-and-air mixtures with frequent monitoring intraoperatively every 30 minutes, IV fentanyl infusion at rate of 0.1 μg/kg/hr may be used if needed.

Non steroidal anti-inflammatory as ketobrufen will be given intraoperatively at dose of (0.5-0.75mg/kg)then postoperatively every eight hours at the same dose.

The reverse of muscle relaxant with safe extubation will be done at the end of surgery.

-PCA morphine 2mg within five minutes lock out interval will be given postoperatively when there is pain.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Study First Posted: 2020-03-19
• Last Update Posted: 2020-03-19
• Primary Completion: 2020-12
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient subjected to major upper abdominal cancer surgery.
• The enrolled age will be from 18-70 years old.
• ASA: I-III, NYHA: I-III.

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Exclusion Criteria

• ASA & physical status (NYHA) > III.
• Pregnant women.
• Body mass index >40 kg/m2.
• Pre-operative opioid consumption.
• Contraindication or patient's refusal of the procedure.
• Un co-operative patient.
• Coagulopathy, skin infection, significant organ dysfunction or drug allergy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Levobupivacaine	patients will receive 20 ml of normal saline into interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side.
Group B	Levobupivacaine	Patients will receive 20 mg 0.25% Levobupivacaine into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side.

Primary Outcome Measures

Name	Time	Method
morphine consumption	24 hours	Decrease morphine consumption.

Secondary Outcome Measures

Name	Time	Method
blood gas	24 hours	-Blood gases will be drawn preoperatively and at 12 hour interval in the PACU for assessment of Oxygen tension (PO2) \& Co2 tension (PCO2).
Hemodynamic	24 hours	- Hemodynamic variables including (systolic and diastolic BP, heart rate, oxygen saturation \& respiratory rate) measured preoperatively (baseline measurement) then immediately postoperative and at 2, 4 ,6 ,12\& 24 hours after surgery.
VAS score	24 hours	Intensity of pain at rest and during pain-provoking movements (deep breathing,coughing, mobilization) measured by VAS pain score immediately postoperative then at 2, 4 ,6 ,12\& 24 hours after surgery}
patient satisfaction	24 hours	patient satisfaction in the first 24 hour post operatively.

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assiut, Egypt