Comparing Erector Spinae Plane (ESP) and Transversus Abdominis Plane (TAP) Block in Inguinal Hernia

NCT04750512 | Completed

• 1 other identifier: ORBV - CHIR - TAPESP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Erectore Spinae Plane Block (ESP Block) is a recently described technique for regional anesthesia that has shown promising results in the treatment of pain after thoracic surgery. It involves the injection of local anesthetic behind the musculature of the back. The investigators intend to compare this technique with a more standardized one, the TAP Block, which involves injection of anesthetic behind the musculature of the abdomen. 50 patients undergoing robotic inguinal hernia repair under general anesthesia will be randomly selected to receive, in addition to general anesthesia, either the ESP block or the TAP block. Patients receiving an ESP Block will also receive an injection of saline solution in the TAP injection site, and the other way around. This will prevent preconceived ideas on either technique to influence the evaluationso of the effect. Pain scores and consumption of pain medication will be recorded during the 24 hours following the operation to compare the effect of the two techniques.

Conditions

Inguinal Hernia; Postoperative Pain; Anesthesia, Local; Anesthesia Complication

Outcome Measures

Primary Outcomes (1)

• Highest Visual Analogue Scale

  0 to 100mm, highest equals to more pain

  Between end of sedation and 6 hours after surgery

Secondary Outcomes (5)

• Visual Analogue Scale score at rest and at movement

  1, 3, 6, 12 and 24 hours after surgery

• Total dose of rescue opioids

  in the first 24 hours after surgery

• Time of first walk after surgery

  24 hours

• Episodes of urinary retention

  24 hours

• Need for anti-nausea medication (dosage, doses and time points)

  24 hours

Study Arms (2)

real ESP, placebo TAP

EXPERIMENTAL

US-guided ESP block + sham US-guided TAP block

Procedure: ESP block

real TAP, placebo ESP

ACTIVE COMPARATOR

sham US-guided ESP block + US-guided TAP block before laparoscopic hernia repair

Procedure: TAP block

Interventions

ESP block PROCEDURE

US guided ESP infiltration (saline solution vs Ropivacaine 0.2% according to randomization): bilateral injection of 30ml (60ml total) under US guidance between the deep fascia of erector spinae muscle and the the two transverse process at the level of the 10th thoracic vertebrae

real ESP, placebo TAP

TAP block PROCEDURE

US guided TAP block (saline solution vs Ropivacaine 0.2% according to randomization): bilateral injection of 30ml (total 60ml) under US guidance in the plane between the internal oblique and transversus abdominis muscles at the level of the midaxillary line in the Petit triangle.

real TAP, placebo ESP

Eligibility Criteria

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

You may qualify if:

• Informed Consent as documented by signature
• Patients over 18 years of age
• Planned elective unilateral or bilateral robot-assisted TAPP hernia repair, with mesh placement

You may not qualify if:

• Contraindications to ropivacaine or opioids, e.g. known hypersensitivity or allergy
• Infections at the injection site
• Coagulopathies or ongoing anticoagulant therapy
• Concomitant surgery other than inguinal or umbilical hernia repair
• Pre-operative chronic narcotic usage
• Known chronic pain syndrome
• Prior complex abdominal wall reconstruction
• Frail patients for whom a prolonged sedation can be detrimental
• Women who are pregnant
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to consent or follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Sponsors & Collaborators

• Ghielmini Enea: lead

Study Sites (1)

ORBV

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Related Publications (1)

• Ghielmini EM, Greco L, Spampatti S, Kubli R, Saporito A, La Regina D. Erector Spinae Plane Block versus Transversus Abdominis Plane Block for Robotic Inguinal Hernia Repair: A Blinded, Active-Controlled, Randomized Trial. Pain Physician. 2024 Jan;27(1):27-34.

  PMID: 38285028 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: According to the randomization arm patients will receive: * sham US-guided ESP block + US-guided TAP block before laparoscopic hernia repair * US-guided ESP block + sham US-guided TAP block before laparoscopic hernia repair Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. Personnel not directly involved with patient care will prepare a saline solution and a ropivacaine solution which will be allocated respectively to ESP or TAP block according to randomization. This will allow blinding of patients, care providers and data collectors. Analysis will be done on allocation-concealed data, permitting blinded analysis. Unbliding will be permitted if by doing so harm to one or more patients can be avoided or treated. After information of one of the principal investigators, specific patient allocation will be retrieved from the randomization program.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single center, prospective, randomized, "double-dummy" placebo-blinded, controlled superiority trial in 2 parallel arms comparing the efficacy and safety of the ESP Block and the TAP block on patients undergoing elective robot-assisted inguinal hernia repair.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 11, 2021
• Study Start: January 11, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

CH (1)