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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03515434
Other study ID # TAPvsESP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date May 17, 2018

Study information

Verified date May 2018
Source Maltepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 17, 2018
Est. primary completion date May 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Turkey Maltepe University faculty of medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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