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The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries (TAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165383
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India

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.

Condition or disease Intervention/treatment Phase
Abdominal Cancer Drug: Bupivacaine (Transversus Abdominis Plane Block) Drug: Intravenous Patient Controlled Analgesia (PCA) Morphine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Block in Lower Abdominal OncoSurgeries
Actual Study Start Date : February 11, 2013
Actual Primary Completion Date : July 10, 2014
Actual Study Completion Date : August 20, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: Transversus Abdominis Plane (TAP) Block Group
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.
Drug: Bupivacaine (Transversus Abdominis Plane Block)
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.

Placebo Comparator: Control Group (No TAP Block)
The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.
Drug: Intravenous Patient Controlled Analgesia (PCA) Morphine
PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.




Primary Outcome Measures :
  1. Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group. [ Time Frame: up to 24 hours ]
    In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.


Secondary Outcome Measures :
  1. Total and Good demands for PCA IV Morphine in milligrams in both the groups. [ Time Frame: up to 24 hours ]
    In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165383


Sponsors and Collaborators
Rajiv Gandhi Cancer Institute & Research Center, India
Investigators
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Principal Investigator: Anita Kulkarni, MD Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India 110085
Publications of Results:
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Responsible Party: Dr Anita Kulkarni, Principal Investigator, Rajiv Gandhi Cancer Institute & Research Center, India
ClinicalTrials.gov Identifier: NCT03165383    
Other Study ID Numbers: RGCI & RC
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India:
Transverse Abdominis Plane (TAP) Block
Patient Control Analgesia (PCA)
Additional relevant MeSH terms:
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Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics