The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries (TAP)
Primary Purpose
Abdominal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacaine (Transversus Abdominis Plane Block)
Intravenous Patient Controlled Analgesia (PCA) Morphine
Sponsored by

About this trial
This is an interventional treatment trial for Abdominal Cancer focused on measuring Transverse Abdominis Plane (TAP) Block, Patient Control Analgesia (PCA)
Eligibility Criteria
Inclusion Criteria:
- Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration.
Exclusion Criteria:
- Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Transversus Abdominis Plane (TAP) Block Group
Control Group (No TAP Block)
Arm Description
Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours.
The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.
Outcomes
Primary Outcome Measures
Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.
In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.
Secondary Outcome Measures
Total and Good demands for PCA IV Morphine in milligrams in both the groups.
In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied.
Full Information
NCT ID
NCT03165383
First Posted
May 18, 2017
Last Updated
May 23, 2017
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
1. Study Identification
Unique Protocol Identification Number
NCT03165383
Brief Title
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries
Acronym
TAP
Official Title
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Block in Lower Abdominal OncoSurgeries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 11, 2013 (Actual)
Primary Completion Date
July 10, 2014 (Actual)
Study Completion Date
August 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effective postoperative pain control results in decreased cardiac and pulmonary complications, patient satisfaction and early mobilization. A prospective, randomized comparative study was done of analgesic efficacy, opioid requirement and side effects in patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given. Patient controlled analgesia (PCA) with intravenous morphine was given to both group patients, and total good PCA demands in both the groups was studied.
Detailed Description
Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled in the study. After obtaining written informed consent from all the patients, they were randomly allotted to either Study (TAP) Group or Control group. Standard general anesthesia with endotracheal intubation was performed in all the patients. Preoperatively all patients received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump. After the end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was placed about 6-8 cms in situ. Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8 hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours. The PCA Pump was set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10 minutes. In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours. Total and good PCA demands upto 24 hours was recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer
Keywords
Transverse Abdominis Plane (TAP) Block, Patient Control Analgesia (PCA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transversus Abdominis Plane (TAP) Block Group
Arm Type
Active Comparator
Arm Description
Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours.
Arm Title
Control Group (No TAP Block)
Arm Type
Placebo Comparator
Arm Description
The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine (Transversus Abdominis Plane Block)
Intervention Description
Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.
Intervention Type
Drug
Intervention Name(s)
Intravenous Patient Controlled Analgesia (PCA) Morphine
Intervention Description
PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.
Primary Outcome Measure Information:
Title
Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.
Description
In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Total and Good demands for PCA IV Morphine in milligrams in both the groups.
Description
In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied.
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration.
Exclusion Criteria:
Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Kulkarni, MD
Organizational Affiliation
Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India 110085
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19020158
Citation
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
Results Reference
result
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
result
Learn more about this trial
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries
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