NCT02292095

Brief Summary

The incidence of post-operative pain after open inguinal hernia repair is high and impair the quality of lives of the patients.The purpose of this study is to determine whether transverse abdominis plane block combined with intravenous patient controlled analgesia is superior to intravenous patient controlled analgesia in improving the quality of life and reducing the incidence of chronic post-surgical pain

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2016

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

November 8, 2014

Last Update Submit

November 5, 2015

Conditions

Post-operative PainInguinal Hernia

Keywords

anesthesiatransverse abdominis plane blockpatient controlled intravenous analgesia

Outcome Measures

Primary Outcomes (1)

  • chronic post-surgical pain

    chronic post-surgical pain will be measured by visual analogue scale (VAS)

    3 months postoperatively

Secondary Outcomes (7)

  • acute post-operative pain

    24h, 48h postoperatively and at discharging time

  • analgesia rescue

    post-operative day 1 to 3

  • The incidence of neuropathic pain

    3,6,12 months postoperatively

  • adverse events

    post-operative day 1 to 3

  • quality of life

    3,6,12 months postoperatively

  • +2 more secondary outcomes

Study Arms (2)

TAPB group

EXPERIMENTAL

Participants in this group will receive transverse abdominis plane block combined with patient controlled intravenous analgesia.Transverse abdominis plane block will be guided by ultrasound and 0.75% 20 ml ropivacaine will be injected with the sonographic view at the end of the surgery.Participants in this group will also receive patient controlled intravenous analgesia after surgery,the regimens of patient controlled intravenous analgesia are included tramadol 800 mg, flurbiprofenaxetil 100 mg, and dexamethasone 5 mg with saline added up to a volume of 80 ml in total

Procedure: TAPB group

PCIA group

ACTIVE COMPARATOR

Participants in this group will only receive patient controlled intravenous analgesia after surgery.The formula of the PCIA included tramadol 800 mg, flurbiprofenaxetil 100 mg, and dexamethasone 5 mg with saline added up to a volume of 80 ml in total, they received a loading dose of 2 ml followed by an infusion rate of 1 ml/h with bolus of 2 ml, the lock time was set at 15 min

Procedure: PCIA group

Interventions

TAPB groupPROCEDURE

transverse abdominis plane block will be conducted by ultrasound and a single-injection of 20ml 0.75% ropivacaine will be conducted for nerve block at the end of surgery.After surgery,participants in this group will also receive patient controlled intravenous analgesia.

TAPB group
PCIA groupPROCEDURE

The formula of patient controlled intravenous analgesia included tramadol 800 mg, flurbiprofenaxetil 100 mg, and dexamethasone 5 mg with saline added up to a volume of 80 ml in total, they received a loading dose of 2 ml followed by an infusion rate of 1 ml/h with bolus of 2 ml, the lock time was set at 15 min

PCIA group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of inguinal hernia and will receive open inguinal hernia repair (UHS mesh)
  • men or woman and 18 \~ 80 years old

You may not qualify if:

  • body mass index≤18 or≥35
  • American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade
  • allergic to local anesthetics
  • hepatic or renal failure
  • being pregnant
  • skin infection at the puncture site
  • pre-operative opioid or non-steroidal anti-inflammatory drugs treatment for chronic pain
  • addicted to drugs or alcohol
  • uncontrolled general infection
  • femoral hernia, incisional hernia or other special types of hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Chongqing medical university

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (22)

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    PMID: 9696470BACKGROUND

  • Martinez V, Baudic S, Fletcher D. [Chronic postsurgical pain]. Ann Fr Anesth Reanim. 2013 Jun;32(6):422-35. doi: 10.1016/j.annfar.2013.04.012. Epub 2013 Jun 7. French.

    PMID: 23747211BACKGROUND

  • Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

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  • Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.

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  • Maia Costa Cabral D, Sawaya Botelho Bracher E, Dylese Prescatan Depintor J, Eluf-Neto J. Chronic pain prevalence and associated factors in a segment of the population of Sao Paulo City. J Pain. 2014 Nov;15(11):1081-1091. doi: 10.1016/j.jpain.2014.07.001. Epub 2014 Jul 16.

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    PMID: 23042472BACKGROUND

  • Werner MU. Management of persistent postsurgical inguinal pain. Langenbecks Arch Surg. 2014 Jun;399(5):559-69. doi: 10.1007/s00423-014-1211-9. Epub 2014 May 23.

    PMID: 24849039BACKGROUND

  • Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.

    PMID: 16095934BACKGROUND

  • Galvez R, Marsal C, Vidal J, Ruiz M, Rejas J. Cross-sectional evaluation of patient functioning and health-related quality of life in patients with neuropathic pain under standard care conditions. Eur J Pain. 2007 Apr;11(3):244-55. doi: 10.1016/j.ejpain.2006.02.002. Epub 2006 Mar 24.

    PMID: 16563819BACKGROUND

  • Jiang J, Teng Y, Fan Z, Khan MS, Cui Z, Xia Y. The efficacy of periarticular multimodal drug injection for postoperative pain management in total knee or hip arthroplasty. J Arthroplasty. 2013 Dec;28(10):1882-7. doi: 10.1016/j.arth.2013.06.031. Epub 2013 Aug 1.

    PMID: 23910819BACKGROUND

  • Alavi SM, Ghoreishi SM, Chitsazan M, Ghandi I, Fard AJ, Hosseini SS, Mahjoobifard M, Fani K. Patient-controlled analgesia after coronary bypass: Remifentanil or sufentanil? Asian Cardiovasc Thorac Ann. 2014 Jul;22(6):694-9. doi: 10.1177/0218492313507783. Epub 2013 Nov 18.

    PMID: 24887897BACKGROUND

  • Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.

    PMID: 11020770BACKGROUND

  • Poobalan AS, Bruce J, Smith WC, King PM, Krukowski ZH, Chambers WA. A review of chronic pain after inguinal herniorrhaphy. Clin J Pain. 2003 Jan-Feb;19(1):48-54. doi: 10.1097/00002508-200301000-00006.

    PMID: 12514456BACKGROUND

  • Reinpold WM, Nehls J, Eggert A. Nerve management and chronic pain after open inguinal hernia repair: a prospective two phase study. Ann Surg. 2011 Jul;254(1):163-8. doi: 10.1097/SLA.0b013e31821d4a2d.

    PMID: 21562403BACKGROUND

  • Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989 Feb;157(2):188-93. doi: 10.1016/0002-9610(89)90526-6.

    PMID: 2916733BACKGROUND

  • van Veen RN, Wijsmuller AR, Vrijland WW, Hop WC, Lange JF, Jeekel J. Long-term follow-up of a randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia. Br J Surg. 2007 Apr;94(4):506-10. doi: 10.1002/bjs.5627.

    PMID: 17279491BACKGROUND

  • Amid PK. The Lichtenstein repair in 2002: an overview of causes of recurrence after Lichtenstein tension-free hernioplasty. Hernia. 2003 Mar;7(1):13-6. doi: 10.1007/s10029-002-0088-7. Epub 2002 Oct 5.

    PMID: 12612791BACKGROUND

  • Massaron S, Bona S, Fumagalli U, Battafarano F, Elmore U, Rosati R. Analysis of post-surgical pain after inguinal hernia repair: a prospective study of 1,440 operations. Hernia. 2007 Dec;11(6):517-25. doi: 10.1007/s10029-007-0267-7. Epub 2007 Jul 24.

    PMID: 17646895BACKGROUND

  • Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.

    PMID: 23273105BACKGROUND

  • Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.

    PMID: 19636493BACKGROUND

  • Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Simons MP. Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2014 Apr;18(2):151-63. doi: 10.1007/s10029-014-1236-6. Epub 2014 Mar 20.

    PMID: 24647885BACKGROUND

  • Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

    PMID: 11576144BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeHernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Officials

  • Su Min

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Ren, Master

CONTACT

023-89011061459910606@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Department of Anestheiology and Pain Medicine

Study Record Dates

First Submitted

November 8, 2014

First Posted

November 17, 2014

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

CN(1)