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Post-operative PainNCT00830089

Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery

A study testing Levobupivicaine 0.25% in people with Post-operative Pain and Postoperative Nausea, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Keyhole surgery for bowel disease has brought great benefits, enabling patients to recover quicker from surgery and so return to normal activities. Although keyhole surgery reduces pain following abdominal surgery, it still causes enough pain to require strong pain killing medications such as morphine-like drugs… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Levobupivicaine 0.25%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2009to Dec 2011
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective laparoscopic colorectal resection at the Queen's Medical Centre, Nottingham

Who cannot join

  • Known allergies to the local anaesthetic
  • Any condition which may cause tolerance to opiates (eg chronic opioid use)
  • Inability to use a PCA
  • Patients less than 45kgs for whom local anaesthetic toxicity may become an issue
  • Adults unable to consent for themselves

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

About this study

Official title: A Prospective Randomised Controlled Trial of the Efficacy of a Transversus Abdominis Plane Block in Laparoscopic Colorectal Surgery.

Keyhole surgery for bowel disease has brought great benefits, enabling patients to recover quicker from surgery and so return to normal activities. Although keyhole surgery reduces pain following abdominal surgery, it still causes enough pain to require strong pain killing medications such as morphine-like drugs which, although good pain killers, can have a detrimental effect on the recovery of bowel function, leading to feelings of nausea and vomiting and ultimately delaying recovery. These side-effects can reduce the potential benefits from keyhole surgery and our "fast-track" recovery programmes.

The aim of this project is to assess the effectiveness of a new method of pain control after keyhole bowel surgery. The study involves the injection of local anaesthetic into the abdominal muscles once the patient is anaesthetised. Although use of local anaesthetic is common practice, we are looking at a new technique of injecting it called a transversus abdominis plane (or TAP) block. This technique will attempt to block the pain nerves to the abdomen prior to the operation beginning. We plan to investigate whether this new technique will reduce the amount of pain following keyhole bowel surgery. If successful, it might be used to further enhance people's recovery from bowel surgery.

Read the detailed description

A considerable component of post-operative pain following abdominal surgery arises from the anterior abdominal wall. Although laparoscopic surgery has been shown to reduce post-operative pain scores compared to open surgery, there is still the problem of abdominal pain arising, in particular, from the specimen extraction site. Commonly used regimes to counter this pain include intravenous opiate-based patient-controlled analgesia (PCA) pumps, although such drugs can have a detrimental effect on the post-operative recovery of bowel function and leads to an increased risk of post-operative nausea and vomiting (PONV). The consequence of these gastrointestinal complications is that the benefits to patients of laparoscopic surgery with enhanced recovery programmes are not fully realised.

The benefits of adequate postoperative analgesia include a reduction in the postoperative stress response, reduction in postoperative morbidity, and in colorectal surgery, improved surgical outcome. Other benefits of effective regional analgesic techniques include reduced pain intensity, decrease incidence of side effects from analgesics (such as PONV), and improved patient comfort.

The innervation of the anterior abdominal wall comes from nerve afferents from T6-L1 running in the neurovascular plane which is found between internal oblique and transversus abdominis (TA). The transversus abdominis plane (TAP) block aims to block these nerves with local anaesthetic before they pierce the anterior abdominal wall. It has already shown to be effective in reducing pain in the first 24 hours after a laparotomy when compared to PCA with opiates and shown to have potential in a series of patients undergoing radical prostatectomy.

The potential improvement of this technique is weighed against the added risks of injecting into the neurovascular plane. There is a theoretical risk of a significant flank haematoma as a result of injury to the small vessels running with the nerves. In addition there is the small risk of inadvertent peritoneal puncture although the risk of any subsequent significant injury is very small and would likely be detected at the time of subsequent laparoscopy. Although there is one case report of a needle puncture to the liver due to previously unknown hepatomegaly, the injury was detected at laparotomy and the consequences were insignificant.

Experimental Methods and Design Patients would be randomised to receive either 20mls of local anaesthetic on each side of the abdomen in the TA plane or to receive no additional treatment. Both groups would receive local anaesthetic into the wounds at the end of the procedure. The TAP block would take place after induction of anaesthesia but before commencement of surgery. The TAP block would be carried out in a standardised manner using ultrasound guidance by two experienced anaesthetists with considerable experience in this technique. For blinding purposes, the site of entry on the skin for a TAP block will be covered with a plaster, irrespective of whether a block has been given.

A standardised anaesthetic and a standard post-operative analgesia regimen will be given to both groups.

Patients will be withdrawn from analysis if a colorectal resection does not take place or the surgery is converted to an open procedure, although data will continue to be collected.

Being tested
Levobupivicaine 0.25%
Keywords
Transversus abdominis plane block, Laparoscopic colorectal surgery, Analgesia
Medical subject headings
Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levobupivicaine 0.25%Drug

    Also called Chirocaine

    40mls of 0.25% L-bupivicaine will be injected into the transversus abdominis plane (TAP) under ultrasound guidance - 20mls on either side of the abdomen.

Study groups in NCT00830089
Study groupRoleWhat they receive
TAP blockExperimental40mls of 0.25% L-bupivicaine will be injected into the transversus abdominis plane (TAP) under ultrasound guidance - 20mls on either side of the abdomen.
Receives: Drug: Levobupivicaine 0.25%
Standard careNo interventionNo TAP block is given. Care is otherwise identical to arm 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative intravenous morphine use at 24 hours

    Measured: 24 hours

Secondary outcomes (4)
  1. Pain score (visual analogue scale)

    Measured: 24 hours

  2. Nausea score

    Measured: 24 hours

  3. Length of stay

    Measured: Days

  4. Post-operative complications

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2011
  4. Study completionDec 2011

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00830089
Sponsor's protocol ID
09002
Status last verified
Jan 2012
First submitted
24 Jan 2009
Last updated
19 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.

    PubMed 23389068

Questions about this trial

What is this clinical trial studying?

A study testing Levobupivicaine 0.25% in people with Post-operative Pain and Postoperative Nausea, run by University of Nottingham 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 1 inclusion and 5 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 19 Jan 2012. 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 intravenous morphine use at 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00830089, which also lists 1 linked publication.

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 19 Jan 2012.

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