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Completed

NCT Number: NCT02375100

Transversus Abdominis Plane Block Versus Ilioinguinal Nerve Block for Pain Management in Inguinal Herniorraphy

This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve block for postoperative pain in patients undergoing inguinal herniorraphy with spinal anesthesia. One-third of the patients will receive standard postoperative pain regimen(control group), one-third will receive a transversus abdominis plane block (with ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with ultrasound guidance) in addition to standard postoperative pain regimen. This study is a Randomized prospective open-label controlled study.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients over 18 years old
  • having ASA (American Society of Anesthesiologists) 1 or 2 physical status score preoperatively
  • not having a neuromuscular disease
  • scheduled for elective single sided inguinal herniorraphy operation

Exclusion criteria

  • being under 18 years of age
  • patient refusal
  • having a neuromuscular disease or sensorial neurological deficit covering similar area of effect with peripheral nerve block interventions or the surgical site
  • having ASA 3 or 4 physical status score preoperatively
  • having one of the contraindications to spinal anesthesia and/or to peripheral nerve blocks as listed by NYSORA (New York School of Regional Anesthesia)
  • having emergency surgery or scheduled for bilateral inguinal herniorraphy

Treatment and study plan

Spinal anesthesia

Procedure

All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade

Other names: Spinal Block

transversus abdominis plane block

Procedure

Analgesic intervention which will be performed only to Transversus Abdominis Plane Block arm. It requires 20ml of %0.25 bupivacaine administration through a 22 G. x 4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel from midaxillary line between costal margin and anterior superior iliac spine with ultrasound guidance

Other names: TAP block

Ilioinguinal nerve block

Procedure

Analgesic intervention which will be performed only to Ilioinguinal Nerve Block arm. It requires 10ml of %0.25 bupivacaine administration through a 22 G. x 3-1/8 in. (80 mm) Insulated Echogenic Needle with 30° Bevel between umbilicus and iliac crest where the nerve is detected with ultrasound guidance

Other names: IIN Block

Bupivacaine %0.5 (hyperbaric)

Drug

Other names: Heavy bupivacaine

Bupivacaine %0.25 (isobaric)

Drug

Other names: Plain bupivacaine

25G Quincke needle

Device

Echogenic Needle with 30° bevel

Device

Acetaminophen

Drug

Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely

Other names: Analgesics

Tramadol

Drug

Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)

Other names: Analgesics

Primary outcomes

  1. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: Baseline

  2. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: 2nd hour after surgery

  3. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: 4th hour after surgery

  4. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: 6th hour after surgery

  5. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: 1st day after surgery

  6. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: 2nd day after surgery

  7. Pain Assessment with Verbal Descriptor Scale (VDS)

    Time frame: 1st month after surgery

Secondary outcomes

  1. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: Baseline

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  2. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: 2nd hour after surgery

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  3. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: 4th hour after surgery

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  4. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: 6th hour after surgery

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  5. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: 1st day after surgery

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  6. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: 2nd day after surgery

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  7. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))

    Time frame: 1st month after surgery

    Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

  8. First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)

    Time frame: whenever in 48 hours after surgery

    The time when the patients experience pain perception after surgery for the first time

  9. Additional analgesic requirements

    Time frame: Baseline

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

  10. Additional analgesic requirements

    Time frame: 2nd hour after surgery

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

  11. Additional analgesic requirements

    Time frame: 4th hour after surgery

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

  12. Additional analgesic requirements

    Time frame: 6th hour after surgery

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

  13. Additional analgesic requirements

    Time frame: 1st day after surgery

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

  14. Additional analgesic requirements

    Time frame: 2nd day after surgery

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

  15. Additional analgesic requirements

    Time frame: 1st month after surgery

    Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2015
Registry last updated
Oct 28, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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