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

NCT03035617 | Unknown

• 1 other identifier: HAPPIEST Trial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Wall Defect

Keywords

Bupivacaine

Outcome Measures

Primary Outcomes (2)

• Post-Operative Pain will be graded on visual analogue scale (VAS)

  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.

  Scale will be presented to the participant at 6 hours post procedure.

• Post-Operative Pain

  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.

  Scale will be presented to the participant at 24 hours post procedure.

Secondary Outcomes (1)

• Length of hospital stay

  Upto a maximum of 30 days from procedure

Study Arms (2)

Controlled Arm

PLACEBO COMPARATOR

Mesh will be soaked in normal saline solution as is routinely done.

Other: Saline

Intervention Arm

EXPERIMENTAL

Mesh will be soaked in .5% bupivacaine solution before application.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

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 .

Intervention Arm

Saline OTHER

In control arm mesh will be soaked in normal saline solution as is routinely done.

Controlled Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital Karachi

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (1)

• Chawla T, Shahzad N, Ahmad K, Ali JF. Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial). J Minim Access Surg. 2020 Oct-Dec;16(4):328-334. doi: 10.4103/jmas.JMAS_50_19.

  PMID: 32978352 DERIVED

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tabish U Chawla, FRCS

  Aga Khan University Hospital Karachi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noman Shahzad, FCPS

CONTACT

+923008833313; drns01@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 30, 2017
• Study Start: November 15, 2015
• Primary Completion: April 30, 2017
• Study Completion: May 30, 2017
• Last Updated: January 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)