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

Primary Purpose

Colonic Cancer, Rectal Cancer, Colonic Diverticulum

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound guided Transversus Abdominis Plane (TAP) bock
Local anaesthetic infiltration of laparoscopic port sites
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Cancer focused on measuring TAP block, Laparoscopic hemicolectomy, Laparoscopic anterior resection, laparoscopic colonic resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP block

Local anaesthetic infiltration

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Numerical Rating Pain Scores at 48 Hours Postoperatively
Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain
Nausea Score at 48 Hours Postoperatively
0-10 0= no nausea 10=severe nausea
Time to First Request for Rescue Analgesia
The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered
Time to Mobilisation
Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.
Time to Successful Intake of Fluids
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 will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.
Time to First Bowel Motion
Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.
Time to First Flatus
Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.
Time to Medically Fit to Discharge
Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.
Total Morphine Consumption at 24hours
Nausea at 24hours Post Operatively
Time to Mobilization
Time to Hospital Discharge

Full Information

First Posted
April 18, 2011
Last Updated
January 24, 2020
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01339273
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer, Rectal Cancer, Colonic Diverticulum, Ulcerative Colitis
Keywords
TAP block, Laparoscopic hemicolectomy, Laparoscopic anterior resection, laparoscopic colonic resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Experimental
Arm Description
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
Arm Title
Local anaesthetic infiltration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided Transversus Abdominis Plane (TAP) bock
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Local anaesthetic infiltration of laparoscopic port sites
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine Consumption in the First 48hours After the Operation
Description
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.
Time Frame
48 hours after the operation
Secondary Outcome Measure Information:
Title
Numerical Rating Pain Scores at 48 Hours Postoperatively
Description
Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain
Time Frame
48 hours after the operation
Title
Nausea Score at 48 Hours Postoperatively
Description
0-10 0= no nausea 10=severe nausea
Time Frame
48 hours after the operation
Title
Time to First Request for Rescue Analgesia
Description
The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered
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.
Title
Time to Mobilisation
Description
Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.
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.
Title
Time to Successful Intake of Fluids
Description
Time will be calculated from the nursing notes and patient diary, when the patient had first successful intake of oral 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.
Title
Time to Resumption of Normal Diet
Description
Time will be calculated from the nursing notes and patient diary, when the patient resumed 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.
Title
Time to First Bowel Motion
Description
Time will be calculated from the nursing notes and patient diary, when the patient had the 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.
Title
Time to First Flatus
Description
Time will be calculated from the nursing notes and patient diary, when the patient first passed 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.
Title
Time to Medically Fit to Discharge
Description
Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.
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.
Title
Total Morphine Consumption at 24hours
Time Frame
24 hours
Title
Nausea at 24hours Post Operatively
Time Frame
24 hours
Title
Time to Mobilization
Time Frame
days
Title
Time to Hospital Discharge
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Crabtree, MB,ChB, FRCA
Organizational Affiliation
Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19207712
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.
Results Reference
background
PubMed Identifier
17179269
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.
Results Reference
background
PubMed Identifier
17961838
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.
Results Reference
background
PubMed Identifier
19376789
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. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
Results Reference
background

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

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