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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02292095
• Other study ID #: CYYMZ-002
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 8, 2014
• Last updated: November 5, 2015
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2015
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Li Ren, Master
• Phone: 023-89011061
• Email: 459910606[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Post-operative Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
China	the first affiliated hospital of Chongqing medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (22)

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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. Epub 2007 Jul 24. — View Citation

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. Review. Erratum in: Hernia. 2014 Jun;18(3):443-4. — View Citation

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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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chronic post-surgical pain	chronic post-surgical pain will be measured by visual analogue scale (VAS)	3 months postoperatively	No
Secondary	acute post-operative pain	pain will be measured by visual analogue scale (VAS)	24h, 48h postoperatively and at discharging time	No
Secondary	analgesia rescue	the dosages of opioid or non-opioid analgesic rescue medication	post-operative day 1 to 3	No
Secondary	The incidence of neuropathic pain	the neuropathic pain will be measured by DN4 questionnaire	3,6,12 months postoperatively	No
Secondary	adverse events	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	Yes
Secondary	quality of life	the quality of life of patients will be measured by EQ-5D questionnaire	3,6,12 months postoperatively	No
Secondary	moderate-severe pain	pain will be measured by visual analogue scale (VAS)	3,6,12 months postoperatively	No
Secondary	chronic post-surgical pain	chronic post-surgical pain will be measured by visual analogue scale (VAS)	6 and 12 months postoperatively	No