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

NCT ID: NCT04300153

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-25
• Study Completion Date: 2023-04-08

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.

Detailed Description

Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Unfortunately, 40% of the patients experience moderate-to-severe acute pain in the early period. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was described in 2016. In this prospective, controlled trial, the primary hypothesis is that ultrasound-guided unilateral ESP block will provide an increase in the quality of recovery-15 scores which will be assessed at the postoperative 24th hour following open IHR surgery. The secondary hypothesis is that ESP block will reduce postoperative pain scores, need for rescue analgesia and time to first mobilization.The study will be conducted as a single-center, prospective, randomized, controlled, double-blinded trial in a university hospital. Patients scheduled for an elective unilateral open IHR under spinal anesthesia, will be screened for enrollment to the study. At the end of the operation, patients will be randomized to receive a unilateral ESP block with 30 ml of 0.25% bupivacaine or 30 ml of normal saline at the level of T12 vertebrae. A blinded anesthesiologist will collect outcome measures in the postoperative period.

Conditions

Postoperative Pain; Inguinal Hernia; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ESP Group

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.

Group Type: EXPERIMENTAL

ESP Block

Intervention Type: 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

Global Quality of Recovery-15 score

Intervention Type: OTHER

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

Standard Pain Followup and Monitorization

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

ESP Block

Intervention Type: 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

Global Quality of Recovery-15 score

Intervention Type: OTHER

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

Standard Pain Followup and Monitorization

Intervention Type: 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.

Interventions

ESP Block

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

Intervention Type: PROCEDURE

Global Quality of Recovery-15 score

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

Intervention Type: OTHER

Standard Pain Followup and Monitorization

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: collaborator

Başak Altıparmak

OTHER

Sponsor Role: lead

Responsible Party

Başak Altıparmak

Assoc Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Başak Altıparmak

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University Medical Faculty

Locations

Muğla Sıtkı Koçman University

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20-II

Identifier Type: -

Identifier Source: org_study_id