Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Patient experience moderate to severe pain after abdominal surgery. This post-operative pain
can also contribute to complications such as respiratory impairment, cardiovascular events,
ileus, sleep deprivation and mood disturbance. Opioid based patient-controlled analgesia
(PCA) is commonly employed but opioids have the side effects such as respiratory depression,
nausea and vomiting, sedation, pruritus and urinary retention. Bowel motility can also be
affected. Consequently alternative or adjunct analgesic medications without these
side-effects have been investigated in order to reduce opioid consumption.
Multimodal analgesia is a technique whereby a combination of analgesic drugs with different
modes of action can be used to improve analgesia and decrease adverse effects by virtue of
synergism. Postoperatively, with adjunctive analgesia, PCA morphine consumption as well as
the side effects may be reduced. Non-steroidal anti-inflammatory drugs (NSAIDs) have been
shown to be opioid sparing and decrease the adverse effects of PCA morphine. A recent review
showed that acetaminophen combined with PCA could induce a significant opioid-sparing effect
but the incidence of PCA morphine related side effects were not reduced.
It is common nowadays to give oral analgesic supplements to post-operative patients on PCA
morphine. Tramadol, an analogue of codeine, is one of the choices. However, some of the
patients cannot tolerate the side effects such as nausea, drowsiness, sweating, postural
hypotension and dry mouth. Combination of tramadol 37.5 mg and acetaminophen 375 mg, which
has been used successfully to treat post-operative pain, may improve analgesic response with
better tolerability.
This study is to assess tramadol 37.5 mg and acetaminophen 375 mg combination on the efficacy
of pain control, down stepping of morphine consumption and related adverse events with PCA
use after open colorectal surgeries.
Objectives:
This study aims to compare and evaluate:
- The efficacy of tramadol/acetaminophen combination on postoperative pain relief after
lower abdominal surgeries
- The effects of tramadol/acetaminophen combination on the consumption and the duration of
PCA morphine use
- The adverse effects related to this regimen
- The effects on postoperative bowel function, tolerability of fluid and diet, ambulatory
function, sleep, and duration of hospital stay
- The overall satisfaction of the patients