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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00830089
First received: January 24, 2009
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Post-operative Pain
Postoperative Nausea
Postoperative Complications
Drug: Levobupivicaine 0.25%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial of the Efficacy of a Transversus Abdominis Plane Block in Laparoscopic Colorectal Surgery.

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Post-operative intravenous morphine use at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score (visual analogue scale) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Nausea score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Post-operative complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP block
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.
Drug: Levobupivicaine 0.25%
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.
Other Name: Chirocaine
No Intervention: Standard care
No TAP block is given. Care is otherwise identical to arm 1

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830089

Locations
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Austin Acheson, MD FRCS University of Nottingham
  More Information

No publications provided by University of Nottingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00830089     History of Changes
Other Study ID Numbers: 09002
Study First Received: January 24, 2009
Last Updated: January 18, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Nottingham:
Transversus abdominis plane block
Laparoscopic colorectal surgery
Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pain
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014