Comparison of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Inguinal Hernia Repair

The Effectiveness of Erector Spinae Plane Block and Transversus Abdominis Plane Block for Postoperative Analgesia in Inguinal Hernia Repair Undergoing Spinal Anesthesia

Multimodal analgesia is used to control postoperative pain in inguinal hernia repair. Transversus abdominis plane block is an effective regional anesthesia technique for postoperative analgesia in inguinal hernia repairs. The erector spinae plane block applied to thelow thoracic region was also reported to provide effective analgesia in these surgeries. In this study, we aimed to determine and compare the effects of transversus abdominis plane block and lumbar erector spinae plane block on postoperative pain in inguinal hernia repairs.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: ESP Block; Other: Standard Pain Followup and Monitorization; Procedure: TAP Block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34090
    • Maltepe University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• inguinal hernia repair under spinal anesthesia, ASA 1-2-3

Exclusion Criteria:

• Patient refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Inability to provide informed consent
• Severe kidney or liver disease
• Inability to operate PCA system
• Patient with psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESP Block; Ultrasound-guided Erector spinae plane (ESP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed	Procedure: ESP Block; ESP block will be performed at the finishing of surgery under spinal anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 2-3 cm lateral to T10 spinous process. The erector spinae muscles will be identified superficial to the tip of T10 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of bupivacaine/lidocaine mixture will be injected.; Other: Standard Pain Followup and Monitorization; Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.-24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
Active Comparator: TAP Block; Ultrasound-guided Transversus abdominis plane (TAP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed	Procedure: TAP Block; TAP block will be performed at the finishing of surgery under spinal anesthesia. A linear ultrasound transducer will be placed to lateral aspect of abdomen. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane between transversus abdominis and internal oblique muscles..A total of 30 mL of bupivacaine/lidocaine mixture will be injected.
Sham Comparator: Control; The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.	Other: Standard Pain Followup and Monitorization; Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.-24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	The numeric rating scale (NRS), the reference measurement method, will be used to determine the postoperative pain levels of the patients. Changes in NRS at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tramadol consumption	Postoperative analgesia plan includes patient-controlled analgesia. Patient-controlled analgesia is a self-administered analgesic and a safe interval is programmed by a patient. Patients in all groups will be assessed at the end of 24 hours for tramadol consumed in patient-controlled analgesia devices.The electronic program in patient-controlled analgesia device can determine the amount of time the patient has applied the medication. The instrument's tool will be used for measurements.	24 hours

Collaborators and Investigators

• Sponsor: Maltepe University
• Investigators: Principal Investigator: serkan Tulgar, ass prof, Maltepe University

Publications and helpful links

General Publications

• Venkatraman R, Abhinaya RJ, Sakthivel A, Sivarajan G. Efficacy of ultrasound-guided transversus abdominis plane block for postoperative analgesia in patients undergoing inguinal hernia repair. Local Reg Anesth. 2016 Jan 18;9:7-12. doi: 10.2147/LRA.S93673. eCollection 2016.
• Takebayashi K, Matsumura M, Kawai Y, Hoashi T, Katsura N, Fukuda S, Shimizu K, Inada T, Sato M. Efficacy of transversus abdominis plane block and rectus sheath block in laparoscopic inguinal hernia surgery. Int Surg. 2015 Apr;100(4):666-71. doi: 10.9738/INTSURG-D-14-00193.1.
• Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): May 10, 2018
• Study Completion (Actual): May 17, 2018

Study Registration Dates

• First Submitted: April 21, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: TAPvsESP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No