|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| The use of local anaesthetic in laparoscopic inguinal hernia repair: a randomised clinical trial |
| ISRCTN | ISRCTN80724178 |
| DOI | 10.1186/ISRCTN80724178 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The use of local anaesthetic in laparoscopic inguinal hernia repair: a randomised clinical trial |
| 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 |
| Acronym | LALA |
| Serial number at source | 1.2 |
| 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. |
| Lay 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 |
| Ethics approval | North Wales Research Ethics Committee - West, 23 July 2012, ref: 12/WA/0227 |
| Study design | Single-blind randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Post operative pain following laparoscopic inguinal hernia surgery |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 07/01/2013 |
| Anticipated end date | 07/02/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact stephen.sammut@wales.nhs.uk to request a patient information sheet |
| Target number of participants | 160 |
| Interventions | 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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Betsi Cadwaladr University Health Board (UK) |
| Trial website | |
| Publications | |
| Contact name | Mr Stephen Sammut |
| Address |
Department of General Surgery
Ysbyty Gwynedd |
| City/town | Bangor |
| Zip/Postcode | LL57 2PW |
| Country | United Kingdom |
| Sponsor | National Health Service in Wales (UK) |
| Address |
c/o Dr Tony Shambrook
Ysbyty Gwynedd Betsi Cadwaladr University Health Board |
| City/town | Bangor |
| Zip/Postcode | LL57 2PW |
| Country | United Kingdom |
| Sponsor website: | http://www.wales.nhs.uk/ |
| Date applied | 06/12/2012 |
| Last edited | 28/02/2013 |
| Date ISRCTN assigned | 28/02/2013 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
