Chronic Pain Clinical Trial
Official title:
PAIN PAD Histological and Molecular Mechanisms of Pain in Patient With Chronic Pain From Adhesions
11-20% of patients undergoing abdominal surgery develop chronic abdominal pain. Adhesions are
a common cause of chronic pain following surgery. Adhesions develop after up to 90% of
laparotomies and 70% of laparoscopic surgeries. Obviously, not all adhesions cause pain. It
is still poorly understood why adhesions cause pain in some patients, while other patients
with adhesions experience no pain.
In this study we explore possible mechanism through which adhesions might cause pain. For
this purpose we will assess expression of molecular mediators (such as TRPV-1, SP, and the
neurokinin receptor), histological characteristics, and fecal microbioma that might be
associated with pain.Expression of these factor will be compared to sample from 30 patients
with chronic pain attributed to adhesions, and 30 patients undergoing a reoperation with
adhsiolysis for reasons unrelated to pain.
Introduction and rationale:
11-20% of patients undergoing abdominal surgery develop chronic abdominal pain. Adhesions are
the most common cause of chronic abdominal complaints after surgery. Chronic pain from
adhesions has devastating consequences for quality of life, and one in three patients with
pain from adhesions is opioid dependent.
Adhesions develop after up to 90% of laparotomies and 70% of laparoscopic surgeries.
Obviously, not all adhesions cause pain. It is still poorly understood why adhesions cause
pain in some patients, while other patients with adhesions experience no pain.
In a recent study we demonstrated that in selected patients adhesion-related pain can
effectively be treated by operation with adhesiolysis and application of an adhesion barrier.
However, almost 50% part of patients with adhesion-related pain are not considered a
candidate for surgical treatment, for various reasons.
Exploring the mechanisms that contribute to development of pain in patients with adhesions
could provide novel targets for medical therapies. These could greatly benefit many patients
suffering from adhesion- related pain. Two factors that might explain why some patients with
adhesions develop chronic pain are activation of molecular mechanisms involved in chronic
pain and stimulation of nerve fibers present in adhesions. Specifically type C nerve fibres
are associated with development of neuropathic pain. Further we will also explore differences
in microbioma, which has recently been demonstrated to have an important role in a variety of
abdominal conditions.
Adhesion formation at the molecular level involves a complex interaction of mediators. One
such mediator that might link adhesion formation to nociception is the pro-inflammatory
peptide substance P.(1) Substance P in turn is mediated by Transient Receptor Potential
Vanilloid (TRPV1), which is known to be upregulated in many conditions associated with
chronic pain. There is currently much research in developing new analgesics targeting this
receptor. Previous studies have shown that nerve fibres can be present in adhesive tissue.
Presence of such fibres, and especially type C fibres might be responsible for a neuropathic
type of pain. Stimulation of TRPV1 might also activate type C nerve fibre endings.
Objective:
Quantify and compare expression of molecular mediators (such as TRPV-1, SP, and the
neurokinin receptor) and histological characteristics of adhesions from patients with
postoperative adhesions with and without chronic abdominal pain. Comparison of microbioma in
fecal samples between patients with adhesions with and without chronic abdominal pain
Study design:
This is a prospective observational cohort study.
Study population:
30 patients eligible for adhesiolysis because of chronic adhesion-related pain. Patients are
recruited at the RadboudUMC, MUMC+ and Pantein hospital departments of surgery. These are
patients with chronic pain after previous abdominal surgery who have been selected for
operative treatment after evaluated with CineMRI. CineMRI is used to map adhesions. This
technique has been established to provide insight in localization of adhesions in relation to
the pain, and risk of bowel injury based on extensiveness of adhesions. The control group
will comprise of 30 patients undergoing an abdominal reoperation during which adhesiolysis
has to be performed for reasons other than chronic adhesion-related pain.
Study procedures:
Prior to surgery patients are requested to take a stool sample. During surgery histological
samples of adhesions will be taken during adhesiolysis in both groups. In the control group
histological samples of adhesions will only be taken if it does not require extension of the
incision and if it is not accompanied with additional risk of intraoperative complications
other than necessary for their planned surgery.
Main study parameters/endpoints:
Primary outcome mRNA expression levels of TRPV1 by quantitative polymerase chain reaction
(qPCR) compared between patients with and without chronic pain. Secondary outcomes are TRPV1
protein levels (measured by Westernblot), SP, and neurokinin expression, and the amount and
types of nerve fibres found at histological assessment. Further we will explore microbioma in
feca samples.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
Taking fecal and histological samples for this study does not result in additional operative
risk. Adhesiolysis is often performed during any type of abdominal reoperation. Histological
samples in controls are only taken from adhesions that are easily accessible and not from
dense adhesions in close proximity to bowel or other vulnerable organs. No additional
adhesiolysis apart from biopsy will be performed.
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