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Abdominal HysterectomyPhase 4NCT03443271

Effect of TAP Block on Stress Hormones

A Phase 4 study testing TAP Block with Bupivicaine in people with Abdominal Hysterectomy and Postoperative Pain, run by Aga Khan University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Abdominal Hysterectomy, Postoperative Pain
What is being tested?
TAP Block with Bupivicaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
No sites listed yet
Study dates
17 Jun 2016to 20 Sep 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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

Read the 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

Being tested
TAP Block with Bupivicaine, TAP Block with Placebo drug
Keywords
transversus abdominis plane block, abdominal hysterectomy, stress response
Medical subject headings
Pain, Postoperative, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP Block with BupivicaineProcedure or surgery

    Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.25 % Bupivicaine on each side.

  • TAP Block with Placebo drugProcedure or surgery

    Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.9% Saline on each side.

Study groups in NCT03443271
Study groupRoleWhat they receive
Group T (TAP Block with Bupivicaine)ExperimentalUltrasound guided TAP block will be performed in this group. Bupivicaine 0.25 % 20 ml will be administered in the block on either side.
Receives: Procedure: TAP Block with Bupivicaine
Group C (TAP Block with Placebo drug)Placebo comparatorUltrasound guided TAP block will be performed in this group. 0.9 % Saline 20 ml will be administered in the block on either side.
Receives: Procedure: TAP Block with Placebo drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Cortisol

    Serum cortisol measured in µg/dL

    Measured: 12 hours after surgery

  2. Serum Norepinephrine

    Serum norepinephrine levels in pg/ml

    Measured: 12 hours after surgery

Secondary outcomes (4)
  1. Pain Score

    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

    Measured: 12 hours after surgery

  2. Rescue analgesia

    Number of times rescue analgesia was required

    Measured: 12 hours after surgery

  3. Total amount of opioid consumption

    Total consumption in milligrams from Patient controlled intravenous analgesia machine

    Measured: 12 hours after surgery

  4. Side effects

    Nausea, Vomiting and sedation

    Measured: 12 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start17 Jun 2016
  3. Primary completion19 Sep 2017
  4. Study completion20 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective double blind randomized control trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03443271
Sponsor's protocol ID
4718-Ane-ERC-17
Status last verified
Feb 2018
First submitted
26 Jan 2018
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stanley G, Appadu B, Mead M, Rowbotham DJ. Dose requirements, efficacy and side effects of morphine and pethidine delivered by patient-controlled analgesia after gynaecological surgery. Br J Anaesth. 1996 Apr;76(4):484-6. doi: 10.1093/bja/76.4.484.

    PubMed 8652316
  • Woodhouse A, Mather LE. The effect of duration of dose delivery with patient-controlled analgesia on the incidence of nausea and vomiting after hysterectomy. Br J Clin Pharmacol. 1998 Jan;45(1):57-62. doi: 10.1046/j.1365-2125.1998.00635.x.

    PubMed 9489595
  • Ng A, Swami A, Smith G, Davidson AC, Emembolu J. The analgesic effects of intraperitoneal and incisional bupivacaine with epinephrine after total abdominal hysterectomy. Anesth Analg. 2002 Jul;95(1):158-62, table of contents. doi: 10.1097/00000539-200207000-00028.

    PubMed 12088961
  • Nishiyama T, Yamashita K, Yokoyama T. Stress hormone changes in general anesthesia of long duration: isoflurane-nitrous oxide vs sevoflurane-nitrous oxide anesthesia. J Clin Anesth. 2005 Dec;17(8):586-91. doi: 10.1016/j.jclinane.2005.03.009.

    PubMed 16427527
  • Chae BK, Lee HW, Sun K, Choi YH, Kim HM. The effect of combined epidural and light general anesthesia on stress hormones in open heart surgery patients. Surg Today. 1998;28(7):727-31. doi: 10.1007/BF02484619.

    PubMed 9697266
  • Li Y, Zhu S, Yan M. Combined general/epidural anesthesia (ropivacaine 0.375%) versus general anesthesia for upper abdominal surgery. Anesth Analg. 2008 May;106(5):1562-5, table of contents. doi: 10.1213/ane.0b013e31816d1976.

    PubMed 18420877
  • Yokoyama M, Itano Y, Katayama H, Morimatsu H, Takeda Y, Takahashi T, Nagano O, Morita K. The effects of continuous epidural anesthesia and analgesia on stress response and immune function in patients undergoing radical esophagectomy. Anesth Analg. 2005 Nov;101(5):1521-1527. doi: 10.1213/01.ANE.0000184287.15086.1E.

    PubMed 16244024
  • Ozyuvaci E, Altan A, Karadeniz T, Topsakal M, Besisik A, Yucel M. General anesthesia versus epidural and general anesthesia in radical cystectomy. Urol Int. 2005;74(1):62-7. doi: 10.1159/000082712.

    PubMed 15711112
  • Schricker T, Berroth A, Pfeiffer U, Schreiber M, Malik E, Schmidt M, Goertz A, Georgieff M. Influence of vaginal versus abdominal hysterectomy on perioperative glucose metabolism. Anesth Analg. 1996 Nov;83(5):991-5. doi: 10.1097/00000539-199611000-00016.

    PubMed 8895274
  • Minhas MR, Kamal R, Afshan G, Raheel H. Knowledge, attitude and practice of parturients regarding Epidural Analgesia for labour in a university hospital in Karachi. J Pak Med Assoc. 2005 Feb;55(2):63-6.

    PubMed 15813631
  • Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.

    PubMed 19174373
  • Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

    PubMed 11576144
  • 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.

    PubMed 17179269
  • 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.

  • McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

    PubMed 18165577

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TAP Block with Bupivicaine in people with Abdominal Hysterectomy and Postoperative Pain, run by Aga Khan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Cortisol (time frame: 12 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443271, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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