Transversus Abdominis Plane (TAP) Block for Postoperative... | NCT01339273

NCT01339273

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Numerical Rating Pain Scores at 48 Hours Postoperatively	Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain	48 hours after the operation
Nausea Score at 48 Hours Postoperatively

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Nicholas Crabtree, MB,ChB, FRCA	Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust		Oxford	Oxfordshire	OX3 9DU	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19207712	Background	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.
17179269	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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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 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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

0-10 0= no nausea 10=severe nausea

8 cases converted to open and therefore excluded from analysis. 7 cases had incomplete and missing follow up data from the ward and were excluded from analysis.

Arm/Group Information

ID	Title	Description
BG000	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 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
BG001	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. 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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00028 BG00128 BG00256

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	OG00047.3(36.2 to 58.5) OG00146.7(36.2 to 57.3)

Secondary

Numerical Rating Pain Scores at 48 Hours Postoperatively

Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain

Posted

Mean

Inter-Quartile Range

units on a scale

48 hours after the operation

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

Nausea Score at 48 Hours Postoperatively

0-10 0= no nausea 10=severe nausea

Posted

Median

Inter-Quartile Range

units on a scale

48 hours after the operation

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

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

data were not collected

Posted

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

Time to Mobilisation

Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.

Posted

Median

Full Range

days

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

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.

Posted

Median

Full Range

days

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

Time to Resumption of Normal Diet

Time will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.

Posted

Median

Full Range

days

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

Time to First Bowel Motion

Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.

Posted

Median

Full Range

days

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

Time to First Flatus

Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.

Posted

Median

Full Range

days

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

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.

Posted

Median

Full Range

days

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.

ID	Title	Description
OG000	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 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
OG001	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. 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.

Secondary

Total Morphine Consumption at 24hours

Posted

Mean

95% Confidence Interval

24 hours

ID	Title	Description
OG000	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 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
OG001	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. 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.

Units	Counts
Participants

Secondary

Nausea at 24hours Post Operatively

data lost during follow up

Posted

Median

Inter-Quartile Range

units on a scale

24 hours

ID	Title	Description
OG000	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 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
OG001	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. 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.

Units	Counts

Secondary

Time to Mobilization

data lost in follow up

Posted

Median

Inter-Quartile Range

days

ID	Title	Description
OG000	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 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
OG001	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. 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.

Units	Counts

Secondary

Time to Hospital Discharge

data lost on follow up

Posted

Median

Inter-Quartile Range

days

ID	Title	Description
OG000	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 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
OG001	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. 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.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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			0	36	0	36
EG001	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. 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.			0	35	0	35

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.

Certain Agreements

ID	Term
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms
D004241	Diverticulum, Colon
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D004240	Diverticulum
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D003092	Colitis
D015212	Inflammatory Bowel Diseases

BG00167.8(64.3 to 71.4)

BG00268.3(64.3 to 75.5)

Units	Counts
Participants	OG00028 OG00128

Units	Counts
Participants	OG00028 OG00128

Units	Counts
Participants	OG00028 OG00128

Units	Counts
Participants	OG00028 OG00128