The use of local anaesthetic in laparoscopic inguinal hernia repair: a randomised clinical trial
| ISRCTN | ISRCTN80724178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80724178 |
| Secondary identifying numbers | 1.2 |
- Submission date
- 06/12/2012
- Registration date
- 28/02/2013
- Last edited
- 22/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims:
Inguinal hernias result from protrusion of abdominal contents through the inguinal canal in the groin region and are common. Surgery to repair inguinal hernias is one of the most common operations performed in the UK. The surgery can be done by an open traditional method, which involves repairing the hernia through an incision (cut) in the groin, or through a keyhole method (laparoscopic repair). One advantage of keyhole surgery is that it is generally associated with less pain following surgery, although many patients still experience significant pain. This study is looking only at the keyhole method and is trying to establish if there is any additional benefit of administering local anaesthetic in a specific fashion to the internal lining of the abdomen (the peritoneum). All patients will receive local anaesthetic to the port sites (where the keyhole instruments are inserted), the only variable will be whether additional local anaesthetic is given to the lining of the abdomen. The aim of our study is to establish if there is a benefit of instilling local anaesthetic to the peritoneum during laparoscopic inguinal hernia surgery. Although some surgeons perform this
routinely, previous studies have not shown a clear benefit of the technique.
Who can participate?
Any adult patients undergoing elective groin hernia surgery; both principal types of laparoscopic repair will be included [i.e. totally extra-peritoneal (TEP) and trans abdominal preperitoneal (TAPP) repairs].
What does the study involve?
The patients recruited into the study will have the same operation as another patient who is not recruited undergoing the same procedure. The difference will be at the end of the operation, when they will receive either a type of local anaesthetic or a harmless salt solution (50ml). Whether they receive the local anaesthetic or salty solution will be determined at random prior to the procedure. Patients will be asked to rate the severity of their pain following their operation. They will be contacted at 4-6 weeks following the
operation and again at one year. We hope to recruit 160 patients in total.
What are the possible benefits and risks of participating?
The study may show a benefit of giving local anaesthetic differently and as such help patients undergoing the same procedure in the future.
There is a risk of side effects of local anaesthetics when they are given in high doses but we will not exceed the maximum recommended dose based on patients body weight. There is a theoretical risk of causing a temporary anaesthesia to one of the main nerves (the femoral nerve) that pass through the groin region into the thigh; if this did occur it could potentially delay the discharge of the patient. Patients will be contacted at approximately 1 month and 1 year following their surgery they may find this useful to provide feedback or discuss any concerns that they may have, as follow-up is not routine following this type of surgery.
Where it the study run from?
The study centre will be in Ysbyty Gwynedd, which is a district general hospital in North Wales, UK. Only patients operated on within the hospital will be recruited into the trial.
When is the study starting and how long is it expected to last for?
It is anticipated to start recruiting for the study in early 2013 and recruitment will hopefully be complete by mid-2014. The study will be complete one year following recruitment of the final participant.
Who is funding the study?
Betsi Cadwaladr University Health Board
Who is the main contact?
Mr Stephen Sammut, stephen.sammut@wales.nhs.uk
Mr Anil Lala, anil.lala@wales.nhs.uk
Contact information
Scientific
Department of General Surgery
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
Study information
| Study design | Single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact stephen.sammut@wales.nhs.uk to request a patient information sheet |
| Scientific title | A single-blind randomised trial to assess whether the application of local anaesthetic versus placebo to the peritoneum during laparoscopic inguinal hernia surgery alters the post-operative pain intensity or analgesic requirments in adults |
| Study acronym | LALA |
| Study hypothesis | There is no difference in either pain intensity or analgesic requirements following surgery in patients who undergo laparoscopic repair of an inguinal hernia when additional local anaesthetic is applied to the peritoneum. |
| Ethics approval(s) | North Wales Research Ethics Committee - West, 23/07/2012, ref: 12/WA/0227 |
| Condition | Post operative pain following laparoscopic inguinal hernia surgery |
| Intervention | Levobupivacaine (0.25%) will be compared to placebo (0.9% sodium chloride). A total of 50ml of study solution will be administered to the peritoneum; the proportion of levobupivacaine administered will depend on the patients body weight. All patients will receive 10ml of 0.25% levobupivacaine to the port sites. |
| Intervention type | Other |
| Primary outcome measure | 1. Perceived pain on movement or coughing measured on a VAS scale at one, two and four hours post surgery 2. Total dosage of Fentanyl administered in post-operative period |
| Secondary outcome measures | 1. Perceived pain intensity on movement or coughing at other time points during the first post-operative week (measured at 8 hours, 24 hours and then daily) 2. Use of rescue or break-through medication for pain during the first week post-operatively. (All patients will be given a prescription of paracetamol to take regularly, any pain medication used over-and-above this will be classed as rescue medication.) 3. Time to discharge criteria being met |
| Overall study start date | 07/01/2013 |
| Overall study end date | 07/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Participant inclusion criteria | 1. Age 18 years or older 2. Elective procedure 3. Suspected inguinal hernia 4. Ability to give informed consent 5. At least 24 hours between decision to operate and operation |
| Participant exclusion criteria | 1. History of allergy or sensitivity to local anaesthetics 2. Treatment for chronic pain or long-term analgesic use 3. Conversion to an open repair or laparotomy during the procedure |
| Recruitment start date | 07/01/2013 |
| Recruitment end date | 07/02/2014 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
LL57 2PW
United Kingdom
Sponsor information
Government
c/o Dr Tony Shambrook
Ysbyty Gwynedd
Betsi Cadwaladr University Health Board
Bangor
LL57 2PW
United Kingdom
| Website | http://www.wales.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04a496k07 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/06/2016: No publications found, verifying study status with principal investigator
