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

• ClinicalTrials.gov Identifier: NCT03515434
• Recruitment Status: Completed
• First Posted: May 3, 2018
• Last Update Posted: May 24, 2018
• Sponsor: Maltepe University
• Information provided by (Responsible Party): Asst. Prof. Serkan Tulgar, M.D., Maltepe University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Procedure: ESP Block; Procedure: TAP Block; Other: Standard Pain Followup and Monitorization	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Erector Spinae Plane Block and Transversus Abdominis Plane Block for Postoperative Analgesia in Inguinal Hernia Repair Undergoing Spinal Anesthesia
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: May 10, 2018
• Actual Study Completion Date: May 17, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Numeric Rating Scale [ Time Frame: 24 hours ]
   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").

Secondary Outcome Measures :

1. Tramadol consumption [ Time Frame: 24 hours ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Maltepe University faculty of medicine

Istanbul, Turkey, 34090

Sponsors and Collaborators

Maltepe University

Investigators

• Principal Investigator: serkan Tulgar, ass prof; Maltepe University

More Information

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.

• Responsible Party: Asst. Prof. Serkan Tulgar, M.D., assiatant proffessor, Maltepe University
• ClinicalTrials.gov Identifier: NCT03515434
• Other Study ID Numbers: TAPvsESP
• First Posted: May 3, 2018
• Last Update Posted: May 24, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hernia, Inguinal; Hernia; Pathological Conditions, Anatomical; Hernia, Abdominal