The comparison of pain relieving efficay of subcostal transversus abdominis plane (TAP) catheters with epidural infusion in patients undergoing surgery on their upper abdomen

ISRCTN ISRCTN08486065
DOI https://doi.org/10.1186/ISRCTN08486065
Secondary identifying numbers UHL 10780
Submission date
05/11/2009
Registration date
23/11/2009
Last edited
19/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G Niraj
Scientific

Specialist Registrar
Department of Anaesthesia
University Hospitals of Leicester NHS Trust
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Study information

Study designSingle centre interventional randomised active controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleComparison of analgesic efficacy of oblique subcostal transversus abdominis plane (TAP) catheters with epidural analgesia in patients undergoing upper abdominal surgery.
Study objectivesThe benefits of adequate postoperative analgesia are clear, and include a reduction in the postoperative stress response, reduction in postoperative morbidity and in certain types of surgery, improved surgical outcome. Effective pain control also accelerates recovery from surgery. The benefits of utilising regional analgesic techniques include reduction in pain intensity, decreased incidence of side effects from systemic analgesics and improved patient comfort. A substantial component of the pain experienced by patients after abdominal surgery is derived from the abdominal wall incision.
The Transversus Abdominis Plane (TAP) Block was first described by McDonnell et al as a landmark technique. TAP Block involves blocking the sensory afferents that supply the anterior abdominal wall including the skin, muscles and the parietal peritoneum. Hebbard et al subsequently described an ultrasound guided technique for the TAP block which they named the Posterior TAP block. Hebbard also described another ultrasound-guided technique called the Oblique Subcostal TAP block which provides analgesia for surgery on the upper abdominal wall. There has been a report from Leicester General Hospital of the effectiveness of the oblique subcostal TAP block in providing analgesia in patients who have had surgery on the upper abdominal wall and as effective rescue analgesia in patients in whom the epidural is ineffective. There has also been a recent report of inserting catheters into the oblique subcostal plane and providing analgesia for over 72 hours in patients who have had hepatobiliary surgery.
The initial pilot data collected in Leicester General Hospital reveals that oblique subcostal TAP catheters could be used as a viable alternative to thoracic epidurals in patients undergoing upper abdominal surgery. There have been no clinical trials on the analgesic efficacy of either single shot oblique subcostal TAP blocks or oblique subcostal TAP catheters for surgery on the upper abdominal wall.
Thoracic epidural analgesia has been considered as the ‘gold standard’ in providing pain relief after surgery on the abdominal wall. Although epidural infusions when effective provide excellent analgesia, there is potential for significant side effects like epidural haematoma, epidural abscess, meningitis etc. In patients where the epidural analgesia is ineffective or is contraindicated, the only other effective option for postoperative analgesia is patient controlled analgesia (PCA) with morphine. Large doses of morphine can cause side effects like nausea, vomiting, respiratory depression, sedation etc. Although patients on PCA morphine are comfortable at rest, they have significant pain on movement (poor dynamic analgesia).
Oblique subcostal TAP catheters could be a viable alternative to epidural infusions for providing analgesia during the postoperative period. The block can be performed easily using ultrasound guidance, has an excellent safety profile to date, provides effective dynamic analgesia and has a significant opioid sparing effect. Before the oblique subcostal TAP catheters gain widespread acceptance, they have to be compared against epidural analgesia which is the gold standard in providing postoperative pain relief.
The proposed study involves the utilisation of ultrasound to locate the oblique subcostal transversus abdominis (TAP) plane, insertion of catheters into the TAP plane on each side and comparison of the analgesic efficacy of the TAP catheters with thoracic epidural catheters during the first 72 postoperative hours in patients who have had upper abdominal surgery.

See publications below for more information:
1. Hebbard P. Subcostal Transversus Abdominis Plane block under ultrasound guidance. Anesth Analg 2008; 106: 674-75
2. Niraj G, Kelkar A, Fox A. Oblique subcostal TAP catheters: An alternative to epidural analgesia after upper abdominal surgery? Anaesthesia 2009; 64(10): 1137-1140
Ethics approval(s)Leicestershire, Northamptonshire & Rutland Research Ethics Committee (LNR 1) approved on the 21st of Dec 2009 (ref: LNR 09/H406/80)
Health condition(s) or problem(s) studiedUpper Abdominal Surgery
InterventionPlease note that as of 05/07/10 this trial has been completed. The original anticipated end date was 30/12/10.

1. Ultrasound guided insertion of oblique subcostal transversus abdominis plane (TAP) catheters
2. Thoracic epidural
Intervention typeProcedure/Surgery
Primary outcome measureThe Visual Analogue Scale (VAS) scores at rest and on coughing before surgery and at the 9 time periods after surgery.
Secondary outcome measures1. Post operative categorical nausea scores before surgery and at the 9 time periods after surgery (none = 0; mild = 1; moderate = 2; severe = 3).
2. Patient satisfaction with postoperative analgesia at 24 h, 48 h and 72 h
3. Any complications with either epidural catheters or TAP catheters during first 72 hours after surgery
Overall study start date01/07/2009
Completion date05/07/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants66
Key inclusion criteriaAll patients aged over 18 years who are scheduled for elective upper abdominal surgery involving incisions with the lower end of the incision at or above thoracic T 10 dermatome
1. Bisubcostal incision
2. Unisubcostal incision
3. Upper midline incision
4. Nephrectomy incision
Key exclusion criteria1. Lack of consent including from those patients who lack mental capacity to give informed consent
2. Patients with history of drug allergy to bupivacaine
3. Patients with history of chronic pain conditions: defined as patients with history of pain for above 3 months and who consume regular analgesics for their chronic pain
4. American Society of Anesthesiologists (ASA) Class 4 and 5
5. Upper abdominal surgery where the lower end of the incision extends below T 10 dermatome
Date of first enrolment01/07/2009
Date of final enrolment05/07/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Specialist Registrar
Leicester
LE5 4PW
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Research & Development Office
Leicester General Hospital
Gwendolen Road
Leiceister
LE5 4PW
England
United Kingdom

ROR logo https://ror.org/02fha3693

Funders

Funder type

Hospital/treatment centre

University Hospitals of Leicester NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2011 Yes No
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