Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection

NCT01339273 | Completed Results

• 1 other identifier: Sponsorship review number:113
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery. Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, earlier return of bowel function and earlier hospital discharge. The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)

Conditions

Colonic Cancer; Rectal Cancer; Colonic Diverticulum; Ulcerative Colitis

Keywords

TAP block; Laparoscopic hemicolectomy; Laparoscopic anterior resection; laparoscopic colonic resection

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption in the First 48hours After the Operation

  Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.

  48 hours after the operation

Secondary Outcomes (13)

• Numerical Rating Pain Scores at 48 Hours Postoperatively

  48 hours after the operation

• Nausea Score at 48 Hours Postoperatively

  48 hours after the operation

• Time to First Request for Rescue Analgesia

  After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.

• Time to Mobilisation

  After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.

• Time to Successful Intake of Fluids

  After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.

Study Arms (2)

TAP block

EXPERIMENTAL

Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

Procedure: Ultrasound guided Transversus Abdominis Plane (TAP) bock

Local anaesthetic infiltration

ACTIVE COMPARATOR

Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Procedure: Local anaesthetic infiltration of laparoscopic port sites

Interventions

Ultrasound guided Transversus Abdominis Plane (TAP) bock PROCEDURE

Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

TAP block

Local anaesthetic infiltration of laparoscopic port sites PROCEDURE

Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Local anaesthetic infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Undergoing elective laparoscopic high anterior resection without stoma or laparoscopic right hemicolectomy.
• American Society of Anaesthetists physical status (ASA) 1-3

You may not qualify if:

• Opioid tolerance
• Chronic abdominal pain
• Allergy/Intolerance: Morphine, local anaesthetics
• BMI\>35 Kg/M2
• Previous major abdominal surgery
• High likelihood of conversion to open procedure
• Patients unable to communicate in written and spoken English
• Weight less than 50 kg

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (4)

• Zafar N, Davies R, Greenslade GL, Dixon AR. The evolution of analgesia in an 'accelerated' recovery programme for resectional laparoscopic colorectal surgery with anastomosis. Colorectal Dis. 2010 Feb;12(2):119-24. doi: 10.1111/j.1463-1318.2009.01768.x. Epub 2009 Jan 16.

  PMID: 19207712 BACKGROUND

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

• McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

  PMID: 17961838 BACKGROUND

• El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.

  PMID: 19376789 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Diverticulum, Colon; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticulum; Diverticular Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colitis; Inflammatory Bowel Diseases

Limitations and Caveats

Smaller number of subjects analysed than planned. Presented data should be carefully interpreted (and no conclusions should be drawn) since not enough patients were analyzed.

Results Point of Contact

• Title: Dr Nicholas Crabtree
• Organization: Oxford University Hospitals NHS Trust

nicholas.crabtree@ouh.nhs.uk

01865 221590

Study Officials

• Nicholas Crabtree, MB,ChB, FRCA

  Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 20, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

GB (1)