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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

Tracking Information
First Submitted Date  ICMJE January 26, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date February 23, 2018
Actual Study Start Date  ICMJE June 17, 2016
Actual Primary Completion Date September 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Serum Cortisol [ Time Frame: 12 hours after surgery ]
    Serum cortisol measured in µg/dL
  • Serum Norepinephrine [ Time Frame: 12 hours after surgery ]
    Serum norepinephrine levels in pg/ml
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • 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
  • Rescue analgesia [ Time Frame: 12 hours after surgery ]
    Number of times rescue analgesia was required
  • Total amount of opioid consumption [ Time Frame: 12 hours after surgery ]
    Total consumption in milligrams from Patient controlled intravenous analgesia machine
  • Side effects [ Time Frame: 12 hours after surgery ]
    Nausea, Vomiting and sedation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2018)
Patient satisfaction [ Time Frame: 24 hours after surgery ]
7-point Likert scale (1=strongly disagree, 7=strong¬ly agree)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of TAP Block on Stress Hormones
Official Title  ICMJE 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
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

Detailed Description

Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. It has been shown that surgical pain and trauma can lead to a number of hormonal changes initiated by the neuronal activation of the hypothalamic pituitary-adrenal axis and the sympathetic nervous system, which can have a detrimental effect on the patient. Strenuous effort has been made to inhibit the stress response to surgery and evaluate its outcome.

It has been shown that this stress response is influenced by the mode of anesthesia and postoperative analgesia. A surgery induced stress response blunted by regional technique and the potential benefits of regional analgesia on surgical outcome are still under scrutiny. Among the postoperative analgesic technique, epidural analgesia has shown to significantly abolish the perioperative stress responses after number of surgeries including hysterectomy. In Pakistan only a small proportion of women wants to avail the epidural service due to fears and misconception.

Another modality of regional technique that has gained popularity as a part of multimodal analgesia is transversus abdominis plane (TAP) block. It is a newly developed block involving the nerves of the anterior abdominal wall. The abdominal wall sensory afferents course through the transversus abdominis plane superficial to the transversus abdominis muscle. An important component of the pain experienced by patients after abdominal surgery derives from the abdominal wall incision.

The efficacy of the TAP block in providing postoperative analgesia as a part of multimodal analgesia has been demonstrated in number of surgeries including colonic resection surgery, caesarean delivery, radical prostatectomy and also hysterectomy. In literature search investigators did not find any clinical study that has been carried out to see the effect of TAP block on stress response after hysterectomy. This study is designed to test the hypothesis that the TAP block, as part of a multimodal analgesic regimen, would attenuate stress response after TAH when compared with placebo. The investigators will also see any difference in postoperative pain and rescue analgesic demands and side effects among patients.

Rationale for the study

Background information:

Failure to adequately control postoperative acute pain can have a number of unwanted physiological and psychosocial consequences for the patient including dissatisfaction, myocardial problems, prolonged hospital stay and even the potential progression to chronic pain. Pain associated with abdominal surgery can be very severe and can lead to a number of hormonal changes initiated by the neuronal activation of the hypothalamic pituitary-adrenal axis and the sympathetic nervous system, which can have a detrimental effect on the patient.

Current postoperative analgesic regimens rely heavily on systemic opioid analgesics which are associated with a number of undesirable side effects including nausea, vomiting, constipation, respiratory depression, and many others. In addition developing countries like Pakistan have limited supply of good quality opioids ,thus safer alternatives need to be evaluated. As a result postoperative pain management in a developing country like Pakistan has been less than suboptimal and barriers include general lack of resources in terms of personnel, drug availability and basic equipment

It has been observed that in developing countries only 45% of anesthetist had ready access to morphine and pethidine. Currently, the cost of importing morphine to developing countries is disproportionately high. A survey of opioid costs in 2003 showed that opioid drugs were up to 10 times more expensive in the developing world than in the developed world, after adjustment for differences in gross domestic product. Therefore in order to find the alternatives; local anaesthetic techniques by means of regional analgesic technique can provide excellent postoperative pain relief and their use should be encouraged whenever possible. There is a need to find techniques to improve postoperative analgesia which will decrease the requirement for opioids, are safe, cost effective, easy to perform and acceptable to patients.

TAP block a form of regional analgesia has been investigated as a part of multimodal analgesia and has shown promising result in decreasing the pain scores and opioid consumption but its role in inhibiting the surgical stress response is still not known. TAP block has been practiced at Aga Khan University hospital (AKUH) since 2012 now, but no data regarding its effect on stress hormones has been collected.

Work has been done on epidural analgesia, which is also a type of regional technique and attenuation of stress hormones is seen by the investigators with this form of analgesia. Epidural analgesia is an invasive procedure, which is expensive and requires expertise and equipment. It is not routinely practiced in our part of the world due to the above mentioned reasons. Epidural analgesia is used at AKUH, but it often less acceptable to patients as it is performed near the spinal cord and also because of the cost related issue.

Therefore the rational of this study is to observe, if a less expensive, easy to perform and safer form of regional analgesia like TAP block has an inhibitory effect on the surgical response or not. If favorable results are seen with TAP block, it can be incorporated in the practice guidelines of pain management for abdominal hysterectomies and related surgeries.

Primary Objective

This study is designed to test the hypothesis that the TAP block, as part of a multimodal analgesic regimen, would attenuate stress response after TAH when compared with placebo. An ultrasound (US)-guided TAP block will be performed before surgical incision.

Venous blood samples (20 ml) for metabolic and stress hormones, including cortisol and norepinephrine will be collected before anesthesia (T1) at the time of cannulation, and 30 minutes after incision(T2) 6hrs (T3)and 24 h (T4) after the surgery.

Secondary Objectives The investigators will observe any difference in postoperative pain by numeric rating score (NRS) and rescue analgesic demands by the reading on patient controlled analgesia pump, total opioid consumption and side effects like nausea, vomiting, sedation by scoring them.

Patient satisfaction score by scoring system

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Abdominal Hysterectomy
  • Postoperative Pain
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: TAP Block with Bupivicaine
  • 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.
    Intervention: Procedure: TAP Block with Placebo drug
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2017
Actual Primary Completion Date September 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443271
Other Study ID Numbers  ICMJE 4718-Ane-ERC-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samina Ismail, Aga Khan University
Study Sponsor  ICMJE Aga Khan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samina Ismail Aga Khan University
PRS Account Aga Khan University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP