Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Nicholas Crabtree, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01339273
First received: April 18, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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)


Condition Intervention
Colonic Cancer
Rectal Cancer
Colonic Diverticulum
Ulcerative Colitis
Procedure: Ultrasound guided Transversus Abdominis Plane (TAP) bock
Procedure: Local anaesthetic infiltration of laparoscopic port sites

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection- a Double Blind Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • Morphine consumption in the first 48hours after the operation [ Time Frame: 48 hours after the operation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Numerical rating pain scores at emergence, 6, 12, 24, 48 & 72 hours postoperatively [ Time Frame: 72 hours after the operation ] [ Designated as safety issue: No ]
  • Nausea score at emergence,6, 12, 24, 48 & 72 hours postoperatively [ Time Frame: 72 hours after the operation ] [ Designated as safety issue: No ]
  • Time to first request for rescue analgesia [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered

  • Time to mobilisation [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.

  • Time to successful intake of fluids [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Time will be calculated from the nursing notes and patient diary, when the patient had first successful intake of oral fluids.

  • Time to resumption of normal diet [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Time will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.

  • Time to first bowel motion [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.

  • Time to first flatus [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.

  • Time to medically fit to discharge [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.


Enrollment: 72
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP block
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
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
Active Comparator: Local anaesthetic infiltration
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01339273

Locations
United Kingdom
The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Nicholas Crabtree, MB,ChB, FRCA Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford
  More Information

Publications:
Responsible Party: Dr Nicholas Crabtree, Consultant Anaesthetist, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01339273     History of Changes
Other Study ID Numbers: Sponsorship review number:113
Study First Received: April 18, 2011
Last Updated: December 5, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Oxford University Hospitals NHS Trust:
TAP block
Laparoscopic hemicolectomy
Laparoscopic anterior resection
laparoscopic colonic resection

Additional relevant MeSH terms:
Colitis, Ulcerative
Diverticulum
Diverticulum, Colon
Colitis
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014