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

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

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

Study Overview

• Status: Unknown
• Conditions: Erector Spinae Block Analgesia
• Intervention / Treatment: Drug: Levobupivacaine

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Romany G. Rezk, MSc; Phone Number: 0020 1094521156; Email: romanygamal1986@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 171516
    • Recruiting
    • South Egypt Cancer Institute
    • Contact: Romany G. Rezk, MSc; Phone Number: 0020 1094521156; Email: romanygamal1986@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	Drug: 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.
EXPERIMENTAL: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	Decrease morphine consumption.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	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}	24 hours
patient satisfaction	patient satisfaction in the first 24 hour post operatively.	24 hours
Hemodynamic	- 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.	24 hours
blood gas	-Blood gases will be drawn preoperatively and at 12 hour interval in the PACU for assessment of Oxygen tension (PO2) & Co2 tension (PCO2).	24 hours

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Principal Investigator: Romany G. Rezk, MSc, Specialist

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (ACTUAL): March 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: southECI-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: as we should ask patients and take their consents to share these date

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No