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

Primary Purpose

Postoperative Pain, Inguinal Hernia, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESP Block
Global Quality of Recovery-15 score
Standard Pain Followup and Monitorization
Sponsored by
Başak Altıparmak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring erector spinae plane block, inguinal hernia, interfascial plane, postoperative pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muğla Sıtkı Koçman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ESP Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Numeric Rating Scale (NRS)
A blinded anesthesiologist will assess postoperative pain of the patients during resting and movement at the 1st, 2nd, 4th, 6th, 8th, 12th and 24th hours by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
Rescue analgesia
If Numerical Rating Scale score of the patient is equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Total rescue analgesia need will be recorded.
Mobilization time
If the patient walks with or without help, it will be accepted as the first mobilization. The motor block duration and time for the first mobilization of the patient will be recorded.

Full Information

First Posted
March 5, 2020
Last Updated
April 15, 2023
Sponsor
Başak Altıparmak
Collaborators
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT04300153
Brief Title
The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia After Inguinal Hernia Repair
Official Title
The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia of Patients Undergoing Inguinal Hernia Repair: Randomized, Controlled, Double Blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
April 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Başak Altıparmak
Collaborators
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inguinal Hernia, Acute Pain
Keywords
erector spinae plane block, inguinal hernia, interfascial plane, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ESP Block
Intervention Description
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
Other
Intervention Name(s)
Global Quality of Recovery-15 score
Intervention Description
Global Quality of Recovery-15 score (QoR-15) will be recorded prior to the surgery and at the postoperative 24th hour.
Intervention Type
Other
Intervention Name(s)
Standard Pain Followup and Monitorization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Quality of Recovery-15 score
Description
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)
Time Frame
Postoperative 24th hour
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
A blinded anesthesiologist will assess postoperative pain of the patients during resting and movement at the 1st, 2nd, 4th, 6th, 8th, 12th and 24th hours by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
Time Frame
24 hours
Title
Rescue analgesia
Description
If Numerical Rating Scale score of the patient is equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Total rescue analgesia need will be recorded.
Time Frame
24 hours
Title
Mobilization time
Description
If the patient walks with or without help, it will be accepted as the first mobilization. The motor block duration and time for the first mobilization of the patient will be recorded.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Başak Altıparmak
Organizational Affiliation
Muğla Sıtkı Koçman University Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muğla Sıtkı Koçman University
City
Muğla
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
via email

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

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