Postoperative Complications Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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