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

Erector Spinae Block Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04315454
• Other study ID #: southECI-1
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2019
• Est. completion date: April 2021

Study information

• Verified date: March 2020
• Source: South Egypt Cancer Institute
• Contact: Romany G. Rezk, MSc
• Phone: 1094521156
• Email: romanygamal1986[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erector Spinae Block Analgesia

Intervention

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.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	Decrease morphine consumption.	24 hours
Secondary	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
Secondary	patient satisfaction	patient satisfaction in the first 24 hour post operatively.	24 hours
Secondary	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
Secondary	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