Inguinal HerniasPhase 1NCT00471692
Local Anaesthetic Following Hernia Repair
A Phase 1 study testing Ropivicaine in people with Inguinal Hernias, run by Royal Hobart Hospital at 1 site in Australia.
Trial summary
Inguinal hernia repair is a common surgical procedure. The major current debates revolve around laparoscopic hernia repair. The most recent Cochrane review concluded that laparoscopic inguinal hernia repair was associated with less post operative and chronic pain, shorter convalescence and earlier return to work when… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernias
- What is being tested?
- Ropivicaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2006to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary unilateral inguinal hernia
- Aged 18 years or more
Who cannot join
- Bilateral inguinal hernia repairs to be performed at the same procedure.
- Recurrent inguinal hernia
- Patient unable to give informed consent
- Contraindication to the use of local anaesthetic
- Operation to be performed under local or spinal anaesthetic.
- Contraindication to use of diclofenac, fentanyl or paracetamol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled Study to Compare Ilio Inguinal Nerve Block and Local Wound Irrigation
Inguinal hernia repair is a common surgical procedure. The major current debates revolve around laparoscopic hernia repair. The most recent Cochrane review concluded that laparoscopic inguinal hernia repair was associated with less post operative and chronic pain, shorter convalescence and earlier return to work when compared to open repair (McCormack K, Scott NW, Go PM, Ross S, Grant AM. EU hernia trialist collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003; 1(CD001785.). However, laparoscopic repair has not gained wide acceptance. It is more expensive, technically difficult for the inexperienced surgeon, is associated with rare but potentially more hazardous procedure related complications (Lo CH, Trotter D, Grossberg P. Unusual complications of laparoscopic totally extraperitoneal inguinal hernia repair. ANZ journal of Surgery 2005 Oct, 75(10): 917 - 919.) and unlike open repair, requires a general anaesthetic. Critics state that laparoscopic repair is not suitable for all general surgeons and should be restricted to experts. Two prospective studies have shown that a longer laparoscopic learning curve exists when compared to open surgery. Up to 200 laparoscopic procedures are required to achieve a recurrence rate comparable to open mesh repair. (Bittner R, Schmedt CG, Schwarz J, Kraft K, Leigl BJ. Laparoscopic transperitoneal procedure for routine repair of groin hernia British journal of Surgery 2002 89; 1062 - 1066.) A meta-analysis and large multicentre randomised study have added to these concerns by demonstrating a higher recurrence rate with laparoscopic repair. (Memon MA, Cooper NJ, Memon B, Memon MI, Abrams KR. Meta-analysis of randomised controlled trials comparing open and laparoscopic inguinal hernia repair. British journal of Surgery 2003; 90: 1479 - 1492. Neumayer L, Giobbie-Hurder, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J et al. Open mesh versus laparoscopic mesh repair of inguinal hernias. New England Journal of Medicine 2004; 350: 1819 - 1827.). Over the period 1998 to 2003, in Denmark, the frequency of laparoscopic repair remained constant at 4.5 - 8.0%, the laparoscopic approach being used more frequently for bilateral hernia repairs and recurrent hernia repairs. There was a higher re-operation rate following laparoscopic repair of bilateral inguinal hernias compared to bilateral open hernia repair. (Wara P, Bay-Nielsen M, Juul P, bendix J, Kehlet H. Prospective nationwide analysis of laparoscopic versus Lichenstein repair of inguinal hernia. British Journal of Surgery 2005 92(10); 1277 - 1281.)
Given these issues, a considerable number of adult inguinal hernia repairs will continue to be performed using the open technique. There is the opportunity to improve the results of open repair by potentially improving post operative pain and chronic pain. One method may be to perform an ilio inguinal nerve block. However, this procedure can be complicated by femoral nerve palsy, colonic or small bowel puncture and pelvic haematomas (Johr M, Sossai R. Colonic puncture during ilioinguinal nerve block in a child. Anesth Analg 1999 88 1051 - 1052, Amory C, mariscal A, Guyot E et al. Is ilioinguinal/iliohypogastric nerve block always totally safe in children? Paediatr Anaesth 2003; 13: 164 - 166. Vaisman J. Pelvic hematoma after an ilioinguinal nerve block for orchialgia Anesth Analg 2001 92 1048 - 1049. Notaras MJ. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for inguinal herniorrhaphy. British Journal of Surgery 1995 82: 854. Rosario DJ, Skinner PP, Raftery AT. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for inguinal herniorrhaphy. British journal of Surgery 1994 81: 897. Ghani KR, McMillan R, Paterson-Brown S. Transient femoral nerve palsy following ilio-inguinal nerve blockade for day case inguinal hernia repair. J R Coll Surg Edinb 2002; 47: 626 - 629. Erez I, Buchumensky V, Shenhman Z, et al. Quadriceps paresis in pediatric groin surgery. Pediatr Surg Int 2002; 18: 157 - 158, Vironen J, Neiminen J, Eklund A, Paavolainen P. Randomised clinical trial of Lichtenstein patch or prolene hernia system for inguinal hernia repair. British Journal of Surgery 2006; 93: 33 - 39)), resulting in delayed discharge of patients. It also has a failure rate of 20 - 30% (Lim SL, Ng SB, Tan GM. Ilioinguinal and iliohypogastric nerve block revisited; single shot versus double shot technique for hernia repair in children. Paediatr Anaesth 2002; 12; 255 - 260.) The aim of our study is therefore to assess the role of ilio inguinal nerve block in adult patients undergoing primary inguinal hernia repair.
Read the detailed description
Patients presenting to the Royal Hobart Hospital for open surgery to an inguinal hernia were approached for inclusion to the study. To patient refused entry. Informed consent was obtained and the study was approved by the local ethics and research committees.
Following induction of general anaesthesia, a sealed envelop was opened. This envelop was prepared by the pharmacy department at the Royal Hobart Hospital. This envelope contained two syringes presented sterile, each containing a clear liquid. The syringe labelled ilioinguinal nerve block was given to the anaesthetist for insertion of an "ilioinguinal nerve block" prior to surgical preparation and draping. The second syringe, labelled wound infiltration was given to the scrub nurse for wound irrigation by the surgeon prior to closure of the external oblique aponeurosis. Patients were divided into the following groups:
Group 1 - 20mls 0.5% ropivacaine for ilio inguinal nerve block and 20mls saline for wound irrigation.
Group 2 - 20mls saline for ilioinguinal nerve block by anaesthetist and 20ml ropivacaine 0.5% for wound irrigation
Group 3 - 20mls saline for ilioinguinal nerve block and 20mls saline for wound irrigation.
GA protocol:
- 0.03mg/kg midazolam IV
- 2mcg/kg fentanyl
- Propofol to induce anaesthesia
- Laryngeal mask.
- Maintenance with oxygen/air and sevoflurane
- Dexamethasone 8mg IV for prophylaxis of post operative nausea and vomiting
- 100mg PR diclofenac
- 1g IV paracetamol
Technique for ilioinguinal nerve block:
Puncture site 1cm medial to anterior superior iliac spine and a fascial click is detected before injection of local anaesthetic. i.e. just below external oblique.
All patients were prescribed a fentanyl PCA for 2 hours postoperatively (1000mcg in 50ml normal saline with a bolus dose of 25mcg set for every 3 minutes. No background rate. If the patient was unable to press the button, nursing staff did this until the patient was able to do so). Using the PCA machine we were be able to record the number of PCA requests and the total PCA fentanyl delivered.
Post operative outcome measures. On an hourly basis until discharge, patients were asked to rate their pain as none, mild, moderate or severe. They were also presented with a visual analogue scale for post operative pain.
On day one, two, fourteen and twenty eight post operatively, the patient was telephoned at home and asked to grade their pain on a scale of none, mild, moderate or severe for:
- On going to bed at night
- The worst pain they had overnight
- Getting out of bed in the morning.
Amount of post operative analgesia required will be asked at the time of the telephone call.
Patients were also asked for the time for return to:
- Walking without discomfort
- Exercise without discomfort
- Sexual activity
- Work
All operations were performed by the same consultant surgeon or by a surgical registrar under direct supervision of the consultant surgeon. All patients had a standard prolene mesh repair.
Primary end point. Post operative analgesia requirements. Visual analogue scores.
Secondary end points. Return to normal activities.
Statistics. For an 80% chance of detecting a difference in visual analogue scale with standard deviation of 0.5 and p<0.05, 30 patients would be required in each group.
- Conditions
- Inguinal Hernias
- Being tested
- Ropivicaine
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivicaineDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Normal saline placebo Receives: Drug: Ropivicaine |
| Ropivocaine | Active comparator | Ilioinguinal nerve block with ropivocaine Receives: Drug: Ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative analgesia requirements. Visual analogue scores.
Measured: Hourly following surgery
Secondary outcomes (1)
Return to normal activities.
Measured: 4 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionNov 2009
Why it stopped: Due to high incidence of neurological complication in those with ilioinguinal block
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Hobart Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Stuart Walker, Royal Hobart Hospital
- Investigators
- Stuart walker, Principal investigator, Royal Hobart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471692
- Sponsor's protocol ID
- H0008762
- Status last verified
- Oct 2015
- First submitted
- 8 May 2007
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled Study to Compare Ilio Inguinal Nerve Block and Local Wound Irrigation
- ClinicalTrials.gov ID
- NCT00471692
- Acronym / sponsor ID
- H0008762
- Conditions
- Inguinal Hernias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to high incidence of neurological complication in those with ilioinguinal block
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Hobart HospitalOther government
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inguinal hernia repair is a common surgical procedure. The major current debates revolve around laparoscopic hernia repair. The most recent Cochrane review concluded that laparoscopic inguinal hernia repair was associated with less post operative and chronic pain, shorter convalescence and earlier return to work when compared to open repair (McCormack K, Scott NW, Go PM, Ross S, Grant AM. EU hernia trialist collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003; 1(CD001785.). However, laparoscopic repair has not gained wide acceptance. It is more expensive, technically difficult for the inexperienced surgeon, is associated with rare but potentially more hazardous procedure related complications (Lo CH, Trotter D, Grossberg P. Unusual complications of laparoscopic totally extraperitoneal inguinal hernia repair. ANZ journal of Surgery 2005 Oct, 75(10): 917 - 919.) and unlike open repair, requires a general anaesthetic. Critics state that laparoscopic repair is not suitable for all general surgeons and should be restricted to experts. Two prospective studies have shown that a longer laparoscopic learning curve exists when compared to open surgery. Up to 200 laparoscopic procedures are required to achieve a recurrence rate comparable to open mesh repair. (Bittner R, Schmedt CG, Schwarz J, Kraft K, Leigl BJ. Laparoscopic transperitoneal procedure for routine repair of groin hernia British journal of Surgery 2002 89; 1062 - 1066.) A meta-analysis and large multicentre randomised study have added to these concerns by demonstrating a higher recurrence rate with laparoscopic repair. (Memon MA, Cooper NJ, Memon B, Memon MI, Abrams KR. Meta-analysis of randomised controlled trials comparing open and laparoscopic inguinal hernia repair. British journal of Surgery 2003; 90: 1479 - 1492. Neumayer L, Giobbie-Hurder, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J et al. Open mesh versus laparoscopic mesh repair of inguinal hernias. New England Journal of Medicine 2004; 350: 1819 - 1827.). Over the period 1998 to 2003, in Denmark, the frequency of laparoscopic repair remained constant at 4.5 - 8.0%, the laparoscopic approach being used more frequently for bilateral hernia repairs and recurrent hernia repairs. There was a higher re-operation rate following laparoscopic repair of bilateral inguinal hernias compared to bilateral open hernia repair. (Wara P, Bay-Nielsen M, Juul P, bendix J, Kehlet H. Prospective nationwide analysis of laparoscopic versus Lichenstein repair of inguinal hernia. British Journal of Surgery 2005 92(10); 1277 - 1281.)
Given these issues, a considerable number of adult inguinal hernia repairs will continue to be performed using the open technique. There is the opportunity to improve the results of open repair by potentially improving post operative pain and chronic pain. One method may be to perform an ilio inguinal nerve block. However, this procedure can be complicated by femoral nerve palsy, colonic or small bowel puncture and pelvic haematomas (Johr M, Sossai R. Colonic puncture during ilioinguinal nerve block in a child. Anesth Analg 1999 88 1051 - 1052, Amory C, mariscal A, Guyot E et al. Is ilioinguinal/iliohypogastric nerve block always totally safe in children? Paediatr Anaesth 2003; 13: 164 - 166. Vaisman J. Pelvic hematoma after an ilioinguinal nerve block for orchialgia Anesth Analg 2001 92 1048 - 1049. Notaras MJ. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for inguinal herniorrhaphy. British Journal of Surgery 1995 82: 854. Rosario DJ, Skinner PP, Raftery AT. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for inguinal herniorrhaphy. British journal of Surgery 1994 81: 897. Ghani KR, McMillan R, Paterson-Brown S. Transient femoral nerve palsy following ilio-inguinal nerve blockade for day case inguinal hernia repair. J R Coll Surg Edinb 2002; 47: 626 - 629. Erez I, Buchumensky V, Shenhman Z, et al. Quadriceps paresis in pediatric groin surgery. Pediatr Surg Int 2002; 18: 157 - 158, Vironen J, Neiminen J, Eklund A, Paavolainen P. Randomised clinical trial of Lichtenstein patch or prolene hernia system for inguinal hernia repair. British Journal of Surgery 2006; 93: 33 - 39)), resulting in delayed discharge of patients. It also has a failure rate of 20 - 30% (Lim SL, Ng SB, Tan GM. Ilioinguinal and iliohypogastric nerve block revisited; single shot versus double shot technique for hernia repair in children. Paediatr Anaesth 2002; 12; 255 - 260.) The aim of our study is therefore to assess the role of ilio inguinal nerve block in adult patients undergoing primary inguinal hernia repair.
Detailed description
Patients presenting to the Royal Hobart Hospital for open surgery to an inguinal hernia were approached for inclusion to the study. To patient refused entry. Informed consent was obtained and the study was approved by the local ethics and research committees.
Following induction of general anaesthesia, a sealed envelop was opened. This envelop was prepared by the pharmacy department at the Royal Hobart Hospital. This envelope contained two syringes presented sterile, each containing a clear liquid. The syringe labelled ilioinguinal nerve block was given to the anaesthetist for insertion of an "ilioinguinal nerve block" prior to surgical preparation and draping. The second syringe, labelled wound infiltration was given to the scrub nurse for wound irrigation by the surgeon prior to closure of the external oblique aponeurosis. Patients were divided into the following groups:
Group 1 - 20mls 0.5% ropivacaine for ilio inguinal nerve block and 20mls saline for wound irrigation.
Group 2 - 20mls saline for ilioinguinal nerve block by anaesthetist and 20ml ropivacaine 0.5% for wound irrigation
Group 3 - 20mls saline for ilioinguinal nerve block and 20mls saline for wound irrigation.
GA protocol:
- 0.03mg/kg midazolam IV
- 2mcg/kg fentanyl
- Propofol to induce anaesthesia
- Laryngeal mask.
- Maintenance with oxygen/air and sevoflurane
- Dexamethasone 8mg IV for prophylaxis of post operative nausea and vomiting
- 100mg PR diclofenac
- 1g IV paracetamol
Technique for ilioinguinal nerve block:
Puncture site 1cm medial to anterior superior iliac spine and a fascial click is detected before injection of local anaesthetic. i.e. just below external oblique.
All patients were prescribed a fentanyl PCA for 2 hours postoperatively (1000mcg in 50ml normal saline with a bolus dose of 25mcg set for every 3 minutes. No background rate. If the patient was unable to press the button, nursing staff did this until the patient was able to do so). Using the PCA machine we were be able to record the number of PCA requests and the total PCA fentanyl delivered.
Post operative outcome measures. On an hourly basis until discharge, patients were asked to rate their pain as none, mild, moderate or severe. They were also presented with a visual analogue scale for post operative pain.
On day one, two, fourteen and twenty eight post operatively, the patient was telephoned at home and asked to grade their pain on a scale of none, mild, moderate or severe for:
- On going to bed at night
- The worst pain they had overnight
- Getting out of bed in the morning.
Amount of post operative analgesia required will be asked at the time of the telephone call.
Patients were also asked for the time for return to:
- Walking without discomfort
- Exercise without discomfort
- Sexual activity
- Work
All operations were performed by the same consultant surgeon or by a surgical registrar under direct supervision of the consultant surgeon. All patients had a standard prolene mesh repair.
Primary end point. Post operative analgesia requirements. Visual analogue scores.
Secondary end points. Return to normal activities.
Statistics. For an 80% chance of detecting a difference in visual analogue scale with standard deviation of 0.5 and p<0.05, 30 patients would be required in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: RopivicaineNormal saline placebo |
| Ropivocaine | Active comparator | Drug: RopivicaineIlioinguinal nerve block with ropivocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary unilateral inguinal hernia
- Aged 18 years or more
Key exclusion criteria (6 listed)
- Bilateral inguinal hernia repairs to be performed at the same procedure.
- Recurrent inguinal hernia
- Patient unable to give informed consent
- Contraindication to the use of local anaesthetic
- Operation to be performed under local or spinal anaesthetic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivicaine | Drug | Ropivocaine, placebo |
Primary outcome
Post operative analgesia requirements. Visual analogue scores.
Time frame: Hourly following surgery
1 secondary outcome
Return to normal activities.
Time frame: 4 weeks post operatively
Results and safety
The study was stopped early (reason given: Due to high incidence of neurological complication in those with ilioinguinal block). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart walker principal investigator
Royal Hobart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ropivicaine in people with Inguinal Hernias, run by Royal Hobart Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to high incidence of neurological complication in those with ilioinguinal block). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative analgesia requirements. Visual analogue scores. (time frame: Hourly following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.