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

NCT ID: NCT04315454

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-04-30

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.

Conditions

Erector Spinae Block Analgesia

Study Design

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

Study Groups

Group A

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 Type: PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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

Group B

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.

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: DRUG

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

Interventions

Levobupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Romany Gamal Rezk Bakeet

anesthesia specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romany G. Rezk, MSc

Role: PRINCIPAL_INVESTIGATOR

Specialist

Locations

South Egypt Cancer Institute

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Romany G. Rezk, MSc

Role: CONTACT

romanygamal1986@gmail.com

1094521156 ext. 0020

Facility Contacts

Romany G. Rezk, MSc

Role: primary

romanygamal1986@gmail.com

1094521156 ext. 0020

Other Identifiers

southECI-1

Identifier Type: -

Identifier Source: org_study_id