Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery

Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery: a Randomized Double-blind Study

We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Cancer Surgery
• Intervention / Treatment: Procedure: Erector Spinae Plane block; Procedure: Continuous Wound Infusion

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I-II, weighing 50-90 Kg with Body Mass Index (BMI) 18.5- 29.9 kg/m2

Exclusion Criteria:

• ASA physical status ≥III, pregnancy, body mass index >30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae plane block	Procedure: Erector Spinae Plane block; An ultrasound linear probe is going to be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. . Local infiltration with 2% of lignocaine at the site of needle insertion is going to be administered. Using in plane approach an 18 G Tuohy needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 5 ml of normal saline.
Active Comparator: Continuous wound infusion	Procedure: Continuous Wound Infusion; Towards the end of surgery, a multiholed 15-cm Anesthesia catheter will be placed in the preperitoneal space (the subfascial space between the peritoneum and posterior fascia) under direct vision and to be tunneled via the rectus sheath to the skin, rolled out and exiting laterally and stabilized with an adhesive tape on skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Morphine consumption	48 hours

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No