Analgesic Efficacy of Erector Spinae Infusion Versus Thoracic Epidural for Patients With Upper Abdominal Cancer Surgeries

NCT04776109 | Completed

• 1 other identifier: 521
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural analgesia is considered by many to be the reference standard which has been shown to reduce the intraoperative surgical stress response. However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. This includes the risk of epidural hematoma/abscess ,failure rates hypotension, urinary retention. Also the need for preoperative placement in awake patients, who seem to dislike and sometimes even refuse. It is contra-indicated in the presence of coagulopathy or local sepsis. ESPB is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training. So this study is to compare the postoperative analgesic effect of continous bupivacaine infusion via thoracic epidural versus erector spinae catheters following upper abdominal cancer surgery.

Conditions

Pain Relief in Upper Abdominal Cancer Surgeries

Outcome Measures

Primary Outcomes (1)

• pain intensity measured by 11 points Visual Analogue Scale

  to assess pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by 11 points Visual Analogue Scale (VAS) score in which 0 indicates no pain and 10 indicates the severest pain

  immediately postoperative for 48 hours after surgery.

Secondary Outcomes (2)

• Hemodynamic variable measured by blood pressure in mmHG

  immediately postoperative for 48 hours after surgery.

• Hemodynamic variable measured by heart rate in beats per minute

  immediately postoperative for 48 hours after surgery.

Other Outcomes (1)

• total opioid consumption

  during first 48 hours postoperatively.

Study Arms (2)

(Group of continous thoracic epidural bupivacaine infusion [CEI])

ACTIVE COMPARATOR

Group I : An epidural catheter will be inserted via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T8 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine (sunny-bupivacaine) infusion. Proper placement of the catheter will be verified through an aspiration test and a test dose (2 ml) of lidocaine 2% with adrenaline. At the end of surgery, a 0.2 ml/kg bolus of bupivacaine 0.25% will be administered through the catheter and then an infusion of bupivacaine 0.125% at a rate of 0.1 ml/kg/h will be administered immediately postoperative and continued for 48 hours.

Procedure: erector spinae block

(Group of continous bilateral erector spinae bupivacaine infusions[CESI])

ACTIVE COMPARATOR

Group II : Bilateral erector spinae catheters will be placed at T8 level. Surface anatomy or ultrasound (counting up from the 12th rib) will be used to identify the level of T8 after skin sterilization with the patient on the lateral position. Then a high frequency linear-array ultrasound transducer (Sono Site MW, Bothell, WA, USA) covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, and the transverse Processes with shimmering pleura in between. Next, 2-3 ml of 2% lidocaine will be infiltrated. A catheter will be inserted and secured. The procedure will be repeated on the contralateral side. 20 ml of bupivacaine 0.25% solution will be injected immediately into each catheter then infusion of bupivacaine 0.125% 0.1 ml/kg/h will be continued for 48 hours.

Procedure: erector spinae block

Interventions

erector spinae block PROCEDURE

Bilateral erector spinae catheters will be placed at T8 level. an ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the back muscles and the transverse Processes. Next, 2-3 ml of 2% lidocaine will be infiltrated . A 16-G, 8-cm Tuohy needle will be then introduced medially in the plane of the ultrasound beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle, 10 ml of saline 0.9% will be injected lifting the muscle of the transverse process. A catheter will be inserted into the newly formed space underneath the ES muscle and secured. The procedure will be repeated on the contralateral side. bupivacaine (20 ml of bupivacaine 0.25%) solution will be injected immediately into each catheter then infusion of bupivacaine 0.125% 0.1 ml/kg/h will be continued for 48 hours.

Also known as: thoracic epidural block

(Group of continous bilateral erector spinae bupivacaine infusions[CESI]); (Group of continous thoracic epidural bupivacaine infusion [CEI])

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients subjected to major upper abdominal cancer surgery.
• The enrolled age will be from 18 years to 70 years
• ASA I-II and NYHA I-II.

You may not qualify if:

• ASA physical status \>II, and NYHA \>II
• Patient refusal
• body mass index \>40 kg/m2
• preoperative opioid consumption
• a local infection at the incision site
• a history of hematological disorders or coagulation abnormality
• previous abdominal surgeries, severe hepatic or renal impairment
• Anomalies of vertebral column.
• Pregnant women
• Hypersensitivity to any of used drugs
• chronic pain

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 71511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: First group (Group of continous thoracic epidural bupivacaine infusion \[CEI\]) Second group (Group of continous bilateral erector spinae bupivacaine infusions\[CESI\])

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 1, 2021
• Study Start: February 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: December 11, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

EG (1)