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Completed

NCT Number: NCT03515434

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maltepe University faculty of medicine

Istanbul, 34090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block

Procedure

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

Procedure

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.

Standard Pain Followup and Monitorization

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 3, 2018
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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