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Study to Evaluate Reduction in Pain After Laparoscopic Hernia Repair With Mesh Soaked in Bupivacaine Solution (HAPPIEST)

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ClinicalTrials.gov Identifier: NCT03035617
Recruitment Status : Unknown
Verified January 2017 by Noman Shahzad, Aga Khan University.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Noman Shahzad, Aga Khan University

Brief Summary:

Early post-operative pain and discomfort after laparoscopic repair remains a concern for patients requiring hospital stay and parenteral narcotic analgesics . This quite often proves to be a hindrance in early ambulation, enhances patient discomfort and prevents early discharge from hospital.

Local anesthetics infiltration at wound site after various procedures is known to be effective in reducing immediate post-operative pain , . In case of laparoscopic ventral hernia repair, delivering local anesthetic at site of mesh application can be achieved by soaking the mesh in local anesthetic solution before application. To date there is no evidence regarding impact of soaking mesh in bupivacaine solution before application in case of laparoscopic ventral hernia repair.

OBJECTIVE:

Primary Objective:

To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to normal saline solution on post-operative pain after laparoscopic ventral hernia repair.

Secondary Objective:

To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to saline solution on length of hospital stay after laparoscopic ventral hernia repair.

Study Sample:

Patients with uncomplicated ventral abdominal wall hernia presenting at general surgery clinics of AKUH Karachi who are planned to undergo laparoscopic repair and meet eligibility criteria of inclusion into trial.

SETTINGS:

Study will be conducted in General Surgery Section of Aga Khan University Hospital, Karachi.

Patients will be evaluated in clinic at the time of presentation regarding eligibility to participate in study. Written informed consent will be taken in clinic. A copy of the consent form will be handed over to the patient. Clinical Trial Unit will be informed of the scheduled date and time of the operation. Allocation will be done by the staff at clinical trial unit which will be kept undisclosed to the investigators, patients and outcome assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form according to treatment arm allocation. After the operation first assessment of pain will be done six hours post-operatively using VAS. Second assessment will be done at twenty four hours from end of operation. This assessment will be done directly if patient is admitted in the hospital or will be done on telephone if patient is discharged home.

FOLLOW UP:

Pain assessment will be done using visual analogue scale (VAS). This is validated score to measure level of pain. It ranges from zero to ten. Score of 0 means no pain and score of ten means worst pain one can ever have. Score will be assessed at 6 and 24 hours from procedure.


Condition or disease Intervention/treatment Phase
Abdominal Wall Defect Drug: Bupivacaine Other: Saline Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We propose a parallel design having two arms. In both the arms operative procedure of laparoscopic ventral hernia repair will be the same except solution used to soak the mesh before application. In control arm mesh will be soaked in normal saline solution as is routinely done. In intervention arm mesh will be soaked in .5% bupivacaine solution before application. Twenty ml of .5% bupivacaine will be provided by Institutional Clinical Trial Unit in coded form. Record of the codes will be kept by the clinical trial unit. Soaking will be done for one minute. Participants, investigators and outcome assessors will be blinded of the treatment allocation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Allocation will be done by the staff at clinical trial unit which will be kept undisclosed to the investigators, patients and outcome assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form according to treatment arm allocation.
Primary Purpose: Treatment
Official Title: Post-Operative Pain After Laparoscopic Ventral Hernia Repair, Impact of Mesh Impregnation With Bupivacaine Solution vs. Normal Saline Solution
Actual Study Start Date : November 15, 2015
Estimated Primary Completion Date : April 30, 2017
Estimated Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Placebo Comparator: Controlled Arm
Mesh will be soaked in normal saline solution as is routinely done.
Other: Saline
In control arm mesh will be soaked in normal saline solution as is routinely done.

Experimental: Intervention Arm
Mesh will be soaked in .5% bupivacaine solution before application.
Drug: Bupivacaine
Bupivacaine is long acting local anesthetic drug. Though minimum toxic dose of bupivacaine for intra-peritoneal use is not defined, analgesic effect of its intra-peritoneal use especially after laparoscopic cholecystectomy has been assessed in several interventional studies. Intra-peritoneal use of up to 50ml of .25% , , or up to 20ml of .5% solution has not shown any drug related adverse reactions .




Primary Outcome Measures :
  1. Post-Operative Pain will be graded on visual analogue scale (VAS) [ Time Frame: Scale will be presented to the participant at 6 hours post procedure. ]
    Post-operative pain will be assessed by trained staff. Pain will be graded on visual analogue scale (VAS). VAS is validated scoring system according to which intensity of pain is scored on a scale of 0 to 10, 0 being no pain and 10 being worst pain.

  2. Post-Operative Pain [ Time Frame: Scale will be presented to the participant at 24 hours post procedure. ]
    Post-operative pain will be assessed by trained staff. Pain will be graded on visual analogue scale (VAS). VAS is validated scoring system according to which intensity of pain is scored on a scale of 0 to 10, 0 being no pain and 10 being worst pain.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Upto a maximum of 30 days from procedure ]
    Length of hospital stay will be taken in number of hours from time of end of operation till discharge from hospital.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients of age > 16 Years
  • Both males and females
  • Ventral Abdominal Wall Hernial Defect planned to undergo laparoscopic repair.
  • Ventral Abdominal Wall Hernia is defined as defect in anterior abdominal wall through which contents of abdominal cavity can protrude. Anterior abdominal wall extends from Xiphisternum above to symphysis pubis below and anterior axillary lines laterally.
  • We plan to include both primary and incisional hernias in our study.

Exclusion Criteria:

  • Complicated Ventral Abdominal Wall Hernia (Strangulated, Obstructed)
  • Recurrent Hernias
  • Renal Insufficiency: Serum Creatinine > 1.5
  • Hepatic Insufficiency: Known case of chronic liver disease or Total Bilirubin > 2mg/dl
  • Pregnant or lactating Females
  • Emergency Operations
  • Current or regular use of analgesics for some other indication
  • Patients with known hypersensitivity to the study drug.
  • Refusal to Informed Consent
  • Simultaneous additional surgical procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035617


Contacts
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Contact: Noman Shahzad, FCPS +923008833313 drns01@hotmail.com

Locations
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Pakistan
Aga Khan University Hospital Karachi Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Noman Shahzad, FCPS    +923008833313    drns01@hotmail.com   
Principal Investigator: Tabish U Chawla, FRCS         
Sub-Investigator: Noman Shahzad, FCPS         
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Tabish U Chawla, FRCS Aga Khan University Hospital Karachi

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Responsible Party: Noman Shahzad, Dr, Aga Khan University
ClinicalTrials.gov Identifier: NCT03035617     History of Changes
Other Study ID Numbers: HAPPIEST Trial
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Noman Shahzad, Aga Khan University:
Bupivacaine

Additional relevant MeSH terms:
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Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents