Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
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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 |
- 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.
- 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.
| Estimated Enrollment: | 72 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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 |
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| Contact: Nicholas Crabtree, MB,ChB, FRCA | 01865221590 | nickcrabtree@doctors.org.uk |
| Contact: Anwar Rashid, MBBS, FRCA | 01865221590 | anwarkrashid@hotmail.com |
| United Kingdom | |
| The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust | Recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 9DU | |
| 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: | March 21, 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:
|
Colonic Neoplasms Rectal Neoplasms Colitis Colitis, Ulcerative Diverticulum, Colon Diverticulum Ulcer Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Gastroenteritis Inflammatory Bowel Diseases Pathological Conditions, Anatomical Pathologic Processes Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013