NCT00830089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

January 24, 2009

Last Update Submit

January 18, 2012

Conditions

Post-operative PainPostoperative NauseaPostoperative Complications

Keywords

Transversus abdominis plane blockLaparoscopic colorectal surgeryAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Post-operative intravenous morphine use at 24 hours

    24 hours

Secondary Outcomes (4)

  • Pain score (visual analogue scale)

    24 hours

  • Nausea score

    24 hours

  • Length of stay

    Days

  • Post-operative complications

    1 month

Study Arms (2)

TAP block

EXPERIMENTAL

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%

Standard care

NO INTERVENTION

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

Interventions

Levobupivicaine 0.25%DRUG

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.

Also known as: Chirocaine
TAP block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23389068DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPostoperative ComplicationsAgnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomitingPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Austin Acheson, MD FRCS

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2009

First Posted

January 27, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

GB(1)