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

Primary Purpose

Post-operative Pain, Postoperative Nausea, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Levobupivicaine 0.25%
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Transversus abdominis plane block, Laparoscopic colorectal surgery, Analgesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAP block

Standard care

Arm Description

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.

No TAP block is given. Care is otherwise identical to arm 1

Outcomes

Primary Outcome Measures

Post-operative intravenous morphine use at 24 hours

Secondary Outcome Measures

Pain score (visual analogue scale)
Nausea score
Length of stay
Post-operative complications

Full Information

First Posted
January 24, 2009
Last Updated
January 18, 2012
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT00830089
Brief Title
Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery
Official Title
A Prospective Randomised Controlled Trial of the Efficacy of a Transversus Abdominis Plane Block in Laparoscopic Colorectal Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Postoperative Nausea, Postoperative Complications
Keywords
Transversus abdominis plane block, Laparoscopic colorectal surgery, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No TAP block is given. Care is otherwise identical to arm 1
Intervention Type
Drug
Intervention Name(s)
Levobupivicaine 0.25%
Other Intervention Name(s)
Chirocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative intravenous morphine use at 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score (visual analogue scale)
Time Frame
24 hours
Title
Nausea score
Time Frame
24 hours
Title
Length of stay
Time Frame
Days
Title
Post-operative complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Austin Acheson, MD FRCS
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23389068
Citation
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.
Results Reference
derived

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

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