NCT02375100

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

February 19, 2015

Last Update Submit

October 27, 2015

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (7)

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    Baseline

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    2nd hour after surgery

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    4th hour after surgery

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    6th hour after surgery

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    1st day after surgery

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    2nd day after surgery

  • Pain Assessment with Verbal Descriptor Scale (VDS)

    1st month after surgery

Secondary Outcomes (15)

  • 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))

    Baseline

  • 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))

    2nd hour after surgery

  • 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))

    4th hour after surgery

  • 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))

    6th hour after surgery

  • 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))

    1st day after surgery

  • +10 more secondary outcomes

Study Arms (3)

Intrathecal bupivacaine&analgesics

ACTIVE COMPARATOR

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

Procedure: Spinal AnesthesiaDrug: Bupivacaine %0.5 (hyperbaric)Device: 25G Quincke needleDrug: AcetaminophenDrug: Tramadol

TAP Block with bupivacaine

EXPERIMENTAL

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

Procedure: Spinal AnesthesiaProcedure: Transversus Abdominis Plane BlockDrug: Bupivacaine %0.5 (hyperbaric)Drug: Bupivacaine %0.25 (isobaric)Device: 25G Quincke needleDevice: Echogenic Needle with 30° bevelDrug: AcetaminophenDrug: Tramadol

IlNB with bupivacaine

EXPERIMENTAL

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

Procedure: Spinal AnesthesiaProcedure: Ilioinguinal Nerve BlockDrug: Bupivacaine %0.5 (hyperbaric)Drug: Bupivacaine %0.25 (isobaric)Device: 25G Quincke needleDevice: Echogenic Needle with 30° bevelDrug: AcetaminophenDrug: Tramadol

Interventions

Spinal AnesthesiaPROCEDURE

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

Also known as: Spinal Block
IlNB with bupivacaineIntrathecal bupivacaine&analgesicsTAP Block with bupivacaine
Transversus Abdominis Plane BlockPROCEDURE

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

Also known as: TAP block
TAP Block with bupivacaine
Ilioinguinal Nerve BlockPROCEDURE

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

Also known as: IIN Block
IlNB with bupivacaine
Bupivacaine %0.5 (hyperbaric)DRUG
Also known as: Heavy bupivacaine
IlNB with bupivacaineIntrathecal bupivacaine&analgesicsTAP Block with bupivacaine
Bupivacaine %0.25 (isobaric)DRUG
Also known as: Plain bupivacaine
IlNB with bupivacaineTAP Block with bupivacaine
25G Quincke needleDEVICE
IlNB with bupivacaineIntrathecal bupivacaine&analgesicsTAP Block with bupivacaine
Echogenic Needle with 30° bevelDEVICE
IlNB with bupivacaineTAP Block with bupivacaine
AcetaminophenDRUG

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

Also known as: Analgesics
IlNB with bupivacaineIntrathecal bupivacaine&analgesicsTAP Block with bupivacaine
TramadolDRUG

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

Also known as: Analgesics
IlNB with bupivacaineIntrathecal bupivacaine&analgesicsTAP Block with bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, SpinalAcetaminophenAnalgesicsTramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Officials

  • Onur Okur, MD,Resident

    Izmir Bozyaka Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 2, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

TU(1)