Pain, PostoperativeNCT00508092
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
A study testing local anesthetic administration in people with Pain, Postoperative, run by Royal Berkshire NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- local anesthetic administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to not given
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Lanz incision appendectomy as starting procedure, including those where an alternative cause for symptoms is found at operation and those where incision is later extended/changed (these may be sub grouped at time of analysis)
- Consent obtained
Who cannot join
- Laparoscopic appendectomy
- Appendectomy at time of laparotomy/other incision
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN
About this study
The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges.
Read the detailed description
Local anesthetic is often administered during an operation to reduce post operative wound pain. Whilst this is frequently done during an appendectomy there is currently no evidence to suggest whether there is any benefit to the patient to injecting the local anesthetic deeper to block the nerves supplying abdominal wall sensation, compared to using it just in the skin around the wound.
Comparison: Post operative pain scores following appendectomy for patients given skin infiltration of local anesthetic (pre incision), compared to patients given both preincision wound infiltration and deeper field infiltration with local anesthetic(deep to external oblique).
- Conditions
- Pain, Postoperative
- Being tested
- local anesthetic administration
- Keywords
- appendicectomy, pain, local anaesthetic, nerve block, Post operative pain following appendicectomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anesthetic administrationProcedure or surgery
Pre incision skin infiltration with local anesthetic 0.5% bupivacaine by weight
OR
Pre incision skin infiltration and deeper field infiltration (deep to external oblique) with local anesthetic 0.5% bupivavcaine by weight
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | lanz incision appendectomy Receives: Procedure: local anesthetic administration |
| B | Active comparator | lanz incision appendectomy Receives: Procedure: local anesthetic administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain score
Measured: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
Secondary outcomes (1)
Post operative nausea and vomiting
Measured: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Berkshire NHS Foundation Trust
- Sponsor type
- Other government
- Investigators
- Jonathan K Randall, MRCS, Principal investigator, Royal Berkshire NHS Foundation TrustSimon B Middleton, FRCS, Study chair, Royal Berkshire NHS Foundation TrustArnold Goede, MRCS, Study director, Royal Berkshire NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508092
- Sponsor's protocol ID
- 06/Q1602/168
- Status last verified
- Apr 2008
- First submitted
- 26 Jul 2007
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
- ClinicalTrials.gov ID
- NCT00508092
- Acronym / sponsor ID
- 06/Q1602/168
- Conditions
- Pain, Postoperative
- Keywords
- appendicectomy, pain, local anaesthetic, nerve block, Post operative pain following appendicectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Royal Berkshire NHS Foundation TrustOther government
- Study start
- Jan 2007
- First posted
- 27 Jul 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.
The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges.
Detailed description
Local anesthetic is often administered during an operation to reduce post operative wound pain. Whilst this is frequently done during an appendectomy there is currently no evidence to suggest whether there is any benefit to the patient to injecting the local anesthetic deeper to block the nerves supplying abdominal wall sensation, compared to using it just in the skin around the wound.
Comparison: Post operative pain scores following appendectomy for patients given skin infiltration of local anesthetic (pre incision), compared to patients given both preincision wound infiltration and deeper field infiltration with local anesthetic(deep to external oblique).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: local anesthetic administrationlanz incision appendectomy |
| B | Active comparator | Procedure: local anesthetic administrationlanz incision appendectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Lanz incision appendectomy as starting procedure, including those where an alternative cause for symptoms is found at operation and those where incision is later extended/changed (these may be sub grouped at time of analysis)
- Consent obtained
Key exclusion criteria (2 listed)
- Laparoscopic appendectomy
- Appendectomy at time of laparotomy/other incision
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 |
|---|---|---|
| local anesthetic administrationPre incision skin infiltration with local anesthetic 0.5% bupivacaine by weight OR Pre incision skin infiltration and deeper field infiltration (deep to external oblique) with local anesthetic 0.5% bupivavcaine by weight | Procedure or surgery | A, B |
Primary outcome
Post operative pain score
Time frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
1 secondary outcome
Post operative nausea and vomiting
Time frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
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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.
Jonathan K Randall, MRCS principal investigator
Royal Berkshire NHS Foundation Trust
Simon B Middleton, FRCS study chair
Royal Berkshire NHS Foundation Trust
Arnold Goede, MRCS study director
Royal Berkshire NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anesthetic administration in people with Pain, Postoperative, run by Royal Berkshire NHS Foundation Trust at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 24 Apr 2008. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 pain score (time frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge). 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 24 Apr 2008.