Effect of TAP Block on Stress Hormones

February 21, 2018 updated by: Samina Ismail, Aga Khan University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Cortisol
Time Frame: 12 hours after surgery
Serum cortisol measured in µg/dL
12 hours after surgery
Serum Norepinephrine
Time Frame: 12 hours after surgery
Serum norepinephrine levels in pg/ml
12 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 hours after surgery
Rescue analgesia
Time Frame: 12 hours after surgery
Number of times rescue analgesia was required
12 hours after surgery
Total amount of opioid consumption
Time Frame: 12 hours after surgery
Total consumption in milligrams from Patient controlled intravenous analgesia machine
12 hours after surgery
Side effects
Time Frame: 12 hours after surgery
Nausea, Vomiting and sedation
12 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 24 hours after surgery
7-point Likert scale (1=strongly disagree, 7=strong¬ly agree)
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Samina Ismail, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2016

Primary Completion (Actual)

September 19, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4718-Ane-ERC-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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