Clinical trial NCT01339273: Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
Official title: Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection- a Double Blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Cancer
Rectal Cancer
Colonic Diverticulum
Ulcerative Colitis
Keywords: TAP block
Laparoscopic hemicolectomy
Laparoscopic anterior resection
laparoscopic colonic resection
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: Summary of Study Design The study will be a double blind randomised controlled trial with patients undergoing laparoscopic right hemicolectomy or laparoscopic high anterior resection randomly allocated into two groups, with the study group receiving bilateral TAP blocks followed by a morphine PCA and the control group receiving local anaesthetic infiltration of the laparoscopic port sites and specimen extraction site and a morphine PCA.

A double blind design was chosen to eliminate patient and observer bias in reporting of pain scores.

The presence of the control arm will ensure that any difference observed will be due to the effect of sensory nerve block due to the TAP block than due to the systemic effect of the injected local anaesthetic.

The null hypothesis will be that there is no difference between the groups in the amount of morphine consumed by the patients during 48 hours after the operation. We chose this measurement as an objective but indirect measurement of efficacy of TAP block and pain relief thus received. Measurement of pain with various scoring methods are reliable only when concurrent reduction in consumption of pain killers are demonstrated.

Recruitment and randomisation:

All patients meeting the inclusion criteria will receive a patient information leaflet and an invitation letter to participate in the study during the pre-assessment visit. We aim to recruit 72 patients (36 patients per group).

Informed consent will be taken by one of the investigators on the morning of the surgery, if the exclusion criteria are not applicable. Patients will be allotted consecutive participant numbers starting from one. Patients will be randomly allocated into either the study group and a control group. Randomisation will occur by using computer generated random numbers. Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the controlled drugs cupboard in theatre-6 anaesthetic room of Churchill hospital.Once patient has consented, the anaesthetist will open the corresponding numbered envelope and perform bilateral TAP blocks after induction of general anaesthesia, if the patient is in the study group the surgeons will infiltrate the port sites with local anaesthetic at the end of the procedure if the patient is in the control group.

Blinding:

The study group will receive bilateral TAP blocks with 20mls 0.25% bupivacaine on each side and the skin punctures on either sides will be covered with a small plaster. Patients in the control group will receive subcutaneous infiltration of the laparoscopic port sites and specimen extraction site with equivalent amount bupivacaine at the end of the procedure and small plasters will be stuck on either flanks approximately where the skin punctures for TAP block will be made.

The assessor of pain scores and morphine doses (Recovery nurse \& Colo-rectal house officer) and the patient will be blinded to group allocation.

Patient: Plasters will be stuck on flanks of all the patients both study and control group so that patient will not know if they have received TAP block.

Recovery nurse: During handover to recovery the anaesthetist and scrub nurse will not mention about group allocation.

Colo-rectal house officer: The house officers( Junior Doctors) who will be following up in the ward will not present in the operating theatre, so they will be blinded

The study duration will be from induction of anaesthesia until the patients are medically fit for discharge from hospital. No extra visits other than routinely required for the surgical procedure is expected.

Eligibility 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

Primary outcomes:
measure: Morphine Consumption in the First 48hours After the Operation
timeFrame: 48 hours after the operation
Secondary outcomes:
measure: Numerical Rating Pain Scores at 48 Hours Postoperatively
timeFrame: 48 hours after the operation
measure: Nausea Score at 48 Hours Postoperatively
timeFrame: 48 hours after the operation
measure: Time to First Request for Rescue Analgesia
timeFrame: 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.
measure: Time to Mobilisation
timeFrame: 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.
measure: Time to Successful Intake of Fluids
timeFrame: 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.
measure: Time to Resumption of Normal Diet
timeFrame: 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.
measure: Time to First Bowel Motion
timeFrame: 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.
measure: Time to First Flatus
timeFrame: 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.
measure: Time to Medically Fit to Discharge
timeFrame: 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.
measure: Total Morphine Consumption at 24hours
timeFrame: 24 hours
measure: Nausea at 24hours Post Operatively
timeFrame: 24 hours
measure: Time to Mobilization
timeFrame: days
measure: Time to Hospital Discharge
timeFrame: days
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust
state: Oxfordshire
Study officials:
affiliation: Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford
name: Nicholas Crabtree, MB,ChB, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. Erratum In: Anesth Analg. 2007 May;104(5):1108.
citation: 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.
citation: 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.