The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia After Inguinal Hernia Repair

NCT04300153 | Completed DMC

• 1 other identifier: 20-II
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Different pharmacological approaches and interfascial plane blocks are used to control postoperative pain. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was reported to be effective in different types of surgeries. In this study, the primary aim is to assess the effect of ESP on recovery of patients following open IHR surgery.

Conditions

Postoperative Pain; Inguinal Hernia; Acute Pain

Keywords

erector spinae plane block; inguinal hernia; interfascial plane; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Global Quality of Recovery-15 score

  Global quality of recovery (QoR) score which will be measured by using 15-item QoR-15 questionnaire. This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item)

  Postoperative 24th hour

Secondary Outcomes (3)

• Numeric Rating Scale (NRS)

  24 hours

• Rescue analgesia

  24 hours

• Mobilization time

  24 hours

Study Arms (2)

ESP Group

EXPERIMENTAL

At the end of the skin closure, patients will be positioned in lateral decubitis and unilateral ESP block will be performed with single injection of 30 ml 0.25% bupivacaine at the level of T12 transverse process. All patients will receive intravenous (iv) paracetamol 1000 mg at the arrival to the recovery room. The dosage will be repeated at every 8-hours interval.

Procedure: ESP Block; Other: Global Quality of Recovery-15 score; Other: Standard Pain Followup and Monitorization

Control Group

SHAM COMPARATOR

At the end of the skin closure, patients will be positioned in lateral decubitis and unilateral ESP block will be performed with single injection of 30 ml normal saline at the level of T12 transverse process. All patients will receive intravenous (iv) paracetamol 1000 mg at the arrival to the recovery room. The dosage will be repeated at every 8-hours interval.

Procedure: ESP Block; Other: Global Quality of Recovery-15 score; Other: Standard Pain Followup and Monitorization

Interventions

ESP Block PROCEDURE

At the end of the skin closure, patients will be positioned in lateral decubitis with the involved site lying superiorly. A convex ultrasound probe will be placed over the transverse process of T12 vertebra in longitudinal axis and an 80- mm 21-gauge needle will be inserted in the plane view under aseptic conditions. A unilateral ESP block will be performed with 30 ml 0.25% bupivacaine into the interfascial plane between erector spinae muscle and T12 transverse process

Control Group; ESP Group

Global Quality of Recovery-15 score OTHER

Global Quality of Recovery-15 score (QoR-15) will be recorded prior to the surgery and at the postoperative 24th hour.

Control Group; ESP Group

Standard Pain Followup and Monitorization OTHER

Numeric Rating Scale score will be recorded at the 1.-2.-4.-6.-8.-12.-24.hours. If Numerical Rating Scale score will be equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Numerical Rating Scale scores, the rescue analgesic need and the time for first mobilization of the patient will be recorded and kept in a statistical evaluation.

Control Group; ESP Group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists physical status I-II
• Elective unilateral open inguinal hernia repair under spinal anesthesia

You may not qualify if:

• Coagulation disorder
• Known allergy to study drugs
• Chronic opioid use
• Infection at the injection site
• Use of pain medications
• Psychologic disorder or inability to cooperate Quality of Recovery-15 (QoR-15) test
• Preoperative pain related to inguinal hernia NRS \> 4/10

Sponsors & Collaborators

• Başak Altıparmak: lead
• Muğla Sıtkı Koçman University: collaborator

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal; Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Başak Altıparmak

  Muğla Sıtkı Koçman University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: March 25, 2020
• Primary Completion: April 7, 2023
• Study Completion: April 8, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)