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

NCT ID: NCT05121987

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Erector spinae plane block

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane block

Intervention Type PROCEDURE

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.

Continuous wound infusion

Group Type ACTIVE_COMPARATOR

Continuous Wound Infusion

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Egypt Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abd El-Hameed Osman

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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563

Identifier Type: -

Identifier Source: org_study_id