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Lap TAP Block for Laparoscopic TEP Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial

Primary Purpose

Laparoscopic TAP Block in TEP Inguinal Hernia Repair.

Status
Unknown status
Phase
Phase 3
Locations
Ireland
Study Type
Interventional
Intervention
TAP Block Group
Peri-Portal Block Group
Sponsored by
Mayo General Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Laparoscopic TAP Block in TEP Inguinal Hernia Repair. focused on measuring Laparoscopic, TAP Block, Total extra peritoneal Inguinal hernia repair

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All consecutive ASA grade I-II- III patients undergoing elective unilateral laparoscopic total extra peritoneal (TEP) Inguinal hernia repair
  • Age 18 - 80 yrs, including those who are having recurrent inguinal hernia repair.

Exclusion Criteria:

  • ASA grade IV, V
  • Bilateral inguinal hernia repair
  • BMI > 40 kg/m2
  • Converted to open procedures.
  • Conversion to Transabdominal preperitoneal (TAPP) repair
  • Coagulopathy.
  • Allergy to Bupivacaine.
  • Diagnosis of "chronic pain syndrome".
  • Known alcohol or substance abuse within the last 6 months.
  • Daily Opioid intake.

Sites / Locations

  • Mayo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TAP block group

Peri-Portal block Group

Arm Description

This group will receive 30 ml of 0.25% Bupivacine given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine. They will also receive normal saline injections at port sites, which will be injected before the ports are inserted. 15 ml of normal saline will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports.

They will receive 0.5% Bupivacaine injections at port sites, which will be injected before the ports are inserted. 15 ml of 0.5% Bupivacaine will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports. This group will also receive 30 ml of Normal Saline Injection given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine.

Outcomes

Primary Outcome Measures

Pain Scores
Numerical Analogue score for pain will be recorded at 1, 3, 6 and 24 hours post surgery

Secondary Outcome Measures

Total opioid usage
amount of opioids used in perioperative period will be recorded.
Post operative nausea or vomiting
instances of nausea or vomiting in the post operative period will be recorded

Full Information

First Posted
December 13, 2015
Last Updated
December 15, 2015
Sponsor
Mayo General Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02632136
Brief Title
Lap TAP Block for Laparoscopic TEP Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial
Official Title
Laparoscopic-assisted Transversus Abdominis Plane (TAP) Block for Laparoscopic Total Extra Peritoneal (TEP) Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo General Hospital, Ireland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A newly developed technique of TAP block solely performed by surgeons will be used for postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the periportal wound infiltration in controlling the postoperative pain.
Detailed Description
Hypothesis: A newly developed technique of TAP block solely performed by surgeons will be used for postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the periportal wound infiltration in controlling the postoperative pain. Significance of the study: Postoperative pain control is very important in day case surgery. Use of local anaesthetics has a significant role in this scenario. No study to date examines the use of laparoscopically delivered TAP blocks in TEP hernia repairs. This technique is more reliable, solely performed by surgeons, and is supposed to replace the ultrasound-guided method. The latter is time-consuming, need ultrasound skills and is usually done by anaesthetists. Previous reports have shown advantage for the ultrasound-guided TAP block in controlling postoperative pain for several types of surgery. Our previous study for use of laparoscopically delivered TAP block in Laparoscopic Cholecystectomy has shown significant advantage in pain relief. Among these, four trials have examined the beneficial effect of TAP block for inguinal hernia repair. Two studies controlled against placebo or no block groups, one compared TAP block with periportal infiltration, while another study compared single injection TAP block with continuous TAP block. Three studies used ultrasound to deliver the block. The Fourth study used semi-blind TAP blocks. One of the studies included open inguinal hernia repair as well. The current trial is supposed to be the first one to evaluate the new method and comparing it with the current practice. In addition, the investigators will be using multi-modal analgesia. Methodology: Settings: The study will be conducted in the Department of General surgery at Mayo University Hospital, Ireland. Study design: The current study is a prospective, randomized, Double-blinded parallel trial. Study population: Eighty six consecutive patients undergoing laparoscopic inguinal hernia repair (TEP) will be included in the study, 43 patients is each arm. One group will have surgically-assisted TAP block with bupivacaine and the others will have peri-portal local anesthetic infiltration. The patients will be randomized into two groups using "random number table" technique. The postoperative pain scoring will be recorded by two observers using numerical analog scale (NAS), but neither the patients nor the observers will be informed about the type of analgesia used. Informed consent will be sought from all patients, and ethical approval will be sought from the institutional review board. The study will meet the standards outlined in the Declaration of Helsinki and Good practices. The trial will be registered at www.clinicaltrials.gov. Sample size calculation: SD of pain score = 1.83 (previous report by Mun Gyu Kim et al). Power = 90%. α = 0.05. Sample size per group = 43. Surgery: The surgery will be performed by one general surgeon following standardized surgical approach under general anaesthesia, while the TAP block will be done by one of the two surgeons who are familiar with the technique. The intra-abdominal pressure will be set at the same level (15 mm Hg) for all patients. Intervention: Test group: The TAP block will be performed at lumbar triangle of petit (Triangle bounded by latissmus dorsi posteriorly, external oblique anteriorly and base by iliac crest) using a blunt needle. Local anaesthetic is injected at midaxillary line after establishing the space of Bogros (space between peritoneum and transversalis fascia). All the procedure will be performed under direct visualization of the laparoscope. Digital pressure will applied to define the site of injection. The needle will be inserted at the site of injection till it is short of transversalis fascia and slight tenting is visible . Then the plunger will be withdrawn to exclude vascular placement and the injection will be employed. The site of injection will be inspected from within the space of Bogros. The presence of internal bulge is regarded as the definitive point of the procedure. Control group: Local periportal infiltration will be done at the three ports before the insertion of ports. Dosing: Fixed dose of Bupivacaine (Total: 30 ml of 0.25% for the Test group and 15 ml of 0.5% for control group) will be given to all patients. Test group: Angle of Petit ---- 30 ml of 0.25%. Control group: Camera port ---- 7 ml of 0.5%. Other ports ---- 4 ml of 0.5% each. . Postoperative pain management: Standardized analgesic regimen will be used in the postoperative period. All patients will receive paracetamol 1000 mg / 6 hourly, orally + Dexketoprofen 50 mg (at 8 hrs). For rescue analgesia: Tapentadol 75 mg/ As required. Total opiods used in peri operative period will be recorded. Double blinding: The patient and the observer will not know the control or intervention group. Study end-points: Primary: Pain score at rest and while coughing using the Numerical analog scale (NAS) at 1, 3, 6 and 24 hr. Secondary: Analgesics requirements ( Paracetamol, NSAID and opiods). Nausea and vomiting. Statistical analysis: Group comparison will be done using Student t-test (2-tailed), Pearson chi-square test, and Mann-Whitney test. Alpha will be set at 0.05, and the SSPS 17.0 will be used for the analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic TAP Block in TEP Inguinal Hernia Repair.
Keywords
Laparoscopic, TAP Block, Total extra peritoneal Inguinal hernia repair

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP block group
Arm Type
Active Comparator
Arm Description
This group will receive 30 ml of 0.25% Bupivacine given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine. They will also receive normal saline injections at port sites, which will be injected before the ports are inserted. 15 ml of normal saline will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports.
Arm Title
Peri-Portal block Group
Arm Type
Placebo Comparator
Arm Description
They will receive 0.5% Bupivacaine injections at port sites, which will be injected before the ports are inserted. 15 ml of 0.5% Bupivacaine will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports. This group will also receive 30 ml of Normal Saline Injection given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine.
Intervention Type
Drug
Intervention Name(s)
TAP Block Group
Other Intervention Name(s)
0.25% Bupivacaine
Intervention Description
Transversus Abdominus Plane (TAP) block: Bupivacaine (30 ml of 0.25%)is injected between internal oblique and transveralis facia. The location of needle and the bleb that is formed after the injection is inspected under diect laparoscopic vision.
Intervention Type
Drug
Intervention Name(s)
Peri-Portal Block Group
Other Intervention Name(s)
0.5% Bupivacaine
Intervention Description
15 ml of 0.5% Bupivacaine is injected in the skin and subcutaneous tissue before inserting the ports. 7 ml out of it is injected at sub-umblical port and 4 ml each a the site of other two ports.
Primary Outcome Measure Information:
Title
Pain Scores
Description
Numerical Analogue score for pain will be recorded at 1, 3, 6 and 24 hours post surgery
Time Frame
Within 24 hours post surgery
Secondary Outcome Measure Information:
Title
Total opioid usage
Description
amount of opioids used in perioperative period will be recorded.
Time Frame
within 24 hours perioperative period
Title
Post operative nausea or vomiting
Description
instances of nausea or vomiting in the post operative period will be recorded
Time Frame
24 hours post operative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consecutive ASA grade I-II- III patients undergoing elective unilateral laparoscopic total extra peritoneal (TEP) Inguinal hernia repair Age 18 - 80 yrs, including those who are having recurrent inguinal hernia repair. Exclusion Criteria: ASA grade IV, V Bilateral inguinal hernia repair BMI > 40 kg/m2 Converted to open procedures. Conversion to Transabdominal preperitoneal (TAPP) repair Coagulopathy. Allergy to Bupivacaine. Diagnosis of "chronic pain syndrome". Known alcohol or substance abuse within the last 6 months. Daily Opioid intake.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asif Khan, MBBS, MRCSI
Phone
00353894171595
Email
asif_21khan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Iqbal Z Khan, MRCSI, FRCSI
Phone
00353868214999
Email
iqbalzkhan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asif Khan, MBBS, MRCSI
Organizational Affiliation
Mayo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo University Hospital
City
Castlebar
State/Province
Mayo
ZIP/Postal Code
F23 EH39
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asif Khan, MBBS, MRCSI
Phone
00353894171595
Email
asif_21khan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Iqbal Z Khan, MRCSI, FRCSI
Phone
00353868214999
Email
iqbalzkhan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25899736
Citation
Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.
Results Reference
background
PubMed Identifier
21401554
Citation
Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.
Results Reference
result
PubMed Identifier
25558340
Citation
Kim MG, Kim SI, Ok SY, Kim SH, Lee SJ, Park SY, Yoo JH, Cho A, Hur KY, Kim MJ. Is transverse abdominis plane block effective following local anesthetic infiltration in laparoscopic totally extraperitoneal hernia repair? Korean J Anesthesiol. 2014 Dec;67(6):398-403. doi: 10.4097/kjae.2014.67.6.398. Epub 2014 Dec 29.
Results Reference
result

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Lap TAP Block for Laparoscopic TEP Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial

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