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Effect of TAP Block on Stress Hormones

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ClinicalTrials.gov Identifier: NCT03443271
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Samina Ismail, Aga Khan University

Brief Summary:

Random allocation of patients in two groups; Tap block group (T group) and control group (C group). All patients will receive standard general anesthesia and postoperative pain management. The TAP group patient will receive ultrasound guided (US) TAP block with 20 cc of 0.25% of bupivacaine and control group will receive 20cc of normal saline. TAP block in both groups will be performed with US guidance and the study drug will be injected after complete visualization of the needle tip between the internal oblique and the transversus abdominis muscles.

Venous blood samples (5 ml for each time) for metabolic and stress hormones, including, Serum cortisol and nor-epinephrine will be collected before anesthesia at the time of cannulation (T1),60 minutes after incision(T2), 6hrs (T3)and 12 h (T4) after the surgery.

Postoperatively patient will be put on patient controlled intravenous infusion of nalbuphine


Condition or disease Intervention/treatment Phase
Abdominal Hysterectomy Postoperative Pain Procedure: TAP Block with Bupivicaine Procedure: TAP Block with Placebo drug Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective double blind randomized control trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patients will be randomly allocated in equal groups of 25 each to undergo TAP block (T group) with 20ml of 0.25% bupivacaine per side or TAP block with 20 ml of normal saline on both sides, which will be the control group (C group). The allocation sequence will be generated by a random number table, and group allocation will be concealed in sealed, opaque envelopes, which will not be opened until patient consent will be obtained. The process of randomization and blinding will be done by the clinical trial unit and according to the group allocation; pre-formed sterile syringes will be dispensed by the clinical trial unit to anesthesiologist performing the TAP block. The anesthesiologist performing the TAP block, patients and staff providing postoperative care will be blinded to group assignment.
Primary Purpose: Prevention
Official Title: Effect of Transversus Abdominis Plane (TAP) Block and the Perioperative Stress Response: Randomized Control Trial in Patient Undergoing Total Abdominal Hysterectomy in a Tertiary Care Hospital of Pakistan
Actual Study Start Date : June 17, 2016
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Group T (TAP Block with Bupivicaine)
Ultrasound guided TAP block will be performed in this group. Bupivicaine 0.25 % 20 ml will be administered in the block on either side.
Procedure: TAP Block with Bupivicaine
Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.25 % Bupivicaine on each side.

Placebo Comparator: Group C (TAP Block with Placebo drug)
Ultrasound guided TAP block will be performed in this group. 0.9 % Saline 20 ml will be administered in the block on either side.
Procedure: TAP Block with Placebo drug
Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.9% Saline on each side.




Primary Outcome Measures :
  1. Serum Cortisol [ Time Frame: 12 hours after surgery ]
    Serum cortisol measured in µg/dL

  2. Serum Norepinephrine [ Time Frame: 12 hours after surgery ]
    Serum norepinephrine levels in pg/ml


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 12 hours after surgery ]
    Pain will be measure by a Numeric Rating Score at rest and on movement. Numeric Rating Score will be from 1 to 10 where 1 is no pain and 10 is the most severe pain

  2. Rescue analgesia [ Time Frame: 12 hours after surgery ]
    Number of times rescue analgesia was required

  3. Total amount of opioid consumption [ Time Frame: 12 hours after surgery ]
    Total consumption in milligrams from Patient controlled intravenous analgesia machine

  4. Side effects [ Time Frame: 12 hours after surgery ]
    Nausea, Vomiting and sedation


Other Outcome Measures:
  1. Patient satisfaction [ Time Frame: 24 hours after surgery ]
    7-point Likert scale (1=strongly disagree, 7=strong¬ly agree)



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients scheduled for elective TAH via Pfannenstiel abdominal wall incision under general anaesthesia
  • American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

  • Patients will be excluded if there is patient refusal to participate in the study, history of relevant drug allergy, or medical therapies considered to result in tolerance to opioids, hysterectomy performed for malignancy or inability to use patient control analgesia (PCA) devise

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): NCT03443271


Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Samina Ismail Aga Khan University

Publications:
Netter FH Back and Spinal Cord. In: Netter FH, ed. Atlas of Human Anatomy Summit. New Jersey, USA: The Ciba-Geigy Corporation, 1989:145-55.
Taylor R Jr, Pergolizzi JV, Raffa RB, Munzi E. Opioids: pharmacology, clinical uses and adverse effects. In: Tvildiani D, Gegechkori K, eds. Opioids: Pharmacology, Clinical Uses and Adverse Effects. Hauppauge, NY: Nova Science Publishers, Inc.; 2012:75-94
Webster K. The transversus abdominis plane (TAP) block: Abdominal plane regional anaesthesia. Update Anaesth. 2008; 24:25-30

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Responsible Party: Samina Ismail, Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03443271     History of Changes
Other Study ID Numbers: 4718-Ane-ERC-17
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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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 Samina Ismail, Aga Khan University:
transversus abdominis plane block
abdominal hysterectomy
stress response

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents