Effects of Transverse Abdominis Plane Block Guided by Ultrasound on the Postoperative Analgesia and Quality of Lives Among the Patients Undergo Inguinal Hernia Repair

November 5, 2015 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The incidence of post-operative pain after open inguinal hernia repair is high according to a a larger-sample epidemic research. Meanwhile, the investigators also found the incidence of CPSP of herniorrhaphy was 37.8% among the patients with PCA, and the incidence of neuropathic pain was 37.5% in these patients with CPSP. European hernia society has proposed that local infiltration anesthesia was suggested to all patients without any contraindications who undergo inguinal hernia repair. Transverse abdominis plane block(TABP),which injecting local anesthetics into the interval between obliquus internus abdominis muscle and transverse abdominal muscle could block the abdominal nerve and could alleviate the pain postoperatively. TABP can block the two mainly nerve (iliohypogastric nerve, ilioinguinal nerve) for inguinal hernia repair and so it seems to have a good effects to relieve the pain of inguinal hernia repair. So the investigators conduct the randomized controlled trial to investigate whether transversus 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.

This study was approved by the Medical Ethics Committee of the First Affiliated Hospital of Chongqing Medical University. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group TAPB and group PCIA, and assess the outcomes of the incidence of acute and chronic postoperative pain and the effects of the two methods on the quality of lives of patients undergo inguinal hernia repair.

Participants in group TAPB will receive transversus abdominis plane block guided by ultrasound at the end of the surgery and also receive intravenous patient controlled analgesia after surgery.

Participants in group PCIA will only receive intravenous patient controlled analgesia after surgery.

The primary outcome of the study is VAS scores at rest and in motion at 3 months postoperatively. The secondary outcomes of this study are chronic post-surgical pain at 6 and 12 months postoperatively, acute post-operative pain, rescue medication and the incidence of neuropathic pain at 3, 6,12 months postoperatively, also the quality of life measured by EQ-5D questionnaire, adverse events associated with postoperative analgesia.

This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAPB group
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
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.
Active Comparator: PCIA group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chronic post-surgical pain
Time Frame: 3 months postoperatively
chronic post-surgical pain will be measured by visual analogue scale (VAS)
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute post-operative pain
Time Frame: 24h, 48h postoperatively and at discharging time
pain will be measured by visual analogue scale (VAS)
24h, 48h postoperatively and at discharging time
analgesia rescue
Time Frame: post-operative day 1 to 3
the dosages of opioid or non-opioid analgesic rescue medication
post-operative day 1 to 3
The incidence of neuropathic pain
Time Frame: 3,6,12 months postoperatively
the neuropathic pain will be measured by DN4 questionnaire
3,6,12 months postoperatively
adverse events
Time Frame: post-operative day 1 to 3
adverse events related to analgesia: incomplete analgesia; respiratory depression; over-sedation; nausea and vomiting; local hematoma; local infection; muscle weakness; urinary retention
post-operative day 1 to 3
quality of life
Time Frame: 3,6,12 months postoperatively
the quality of life of patients will be measured by EQ-5D questionnaire
3,6,12 months postoperatively
moderate-severe pain
Time Frame: 3,6,12 months postoperatively
pain will be measured by visual analogue scale (VAS)
3,6,12 months postoperatively
chronic post-surgical pain
Time Frame: 6 and 12 months postoperatively
chronic post-surgical pain will be measured by visual analogue scale (VAS)
6 and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

November 8, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYYMZ-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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