In the current study we will investigate the effect of non-pharmacological treatment on postoperative acute pain and PONV in patients undergoing a laparoscopic cholecystectomy. Patients will receive on the recovery an ice-lolly, chewing gum or no…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Postoperatieve pijn en misselijkheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
After surgery, we will record acute pain intensity levels (using a numerical
rating scale ranging from 0 to 10; 0 = no pain, 10 = most pain imaginable) and
analgesic consumption during the first 24 hours. Furthermore the presence of
PONV will be monitored as well as the need for anti-emetic medication.
Secondary outcome
-
Background summary
Postoperative pain and postoperative nausea and vomiting (PONV) are common
after surgery and a large burden to patients. Not only the site of surgery may
be painful but also anesthesiological interventions, like intubation and the
insertion of an urinary catheter may result in discomfort after surgery. For
example, oral intubation may lead to a sore throat and hoarseness and the
placement of a urinary catheter may result in discomfort in the urinary tract.
PONV are often caused by surgical interventions in the abdomen but also drugs
necessary to induce anesthesia result in postoperative nausea and vomiting.
The management of postoperative pain and PONV is one of the tasks of the
recovery personnel under supervision of the anesthesiologist. Management of
postoperative acute pain is often by the administration of opioids (which by
themselves are a main cause of PONV). PONV is treated by the administration of
anti-emetic drugs. Besides pharmacological interventions, non-pharmacological
interventions may be very useful in the treatment of postoperative pain and
PONV. However, currently, non-pharmacological interventions are not routinely
used on the recovery for the management of pain or nausea and vomiting,
possibly because their effectiveness has never been investigated.
Non-pharmacological interventions have been successfully used in the first week
after surgery. For example, it has been shown that chewing gum in the first
week after abdominal surgery reduces the development of postoperative ileus.
Study objective
In the current study we will investigate the effect of non-pharmacological
treatment on postoperative acute pain and PONV in patients undergoing a
laparoscopic cholecystectomy. Patients will receive on the recovery an
ice-lolly, chewing gum or no non-pharmacological treatment. We believe that
this non-pharmacological treatment may reduce the stress level of patients
direct postoperative and will give distraction from the pain and nausea. This
may result in a reduction of pain intensity levels and analgesic consumption
and a lower incidence of PONV.
We hypothesize that:
1) Patients receiving an ice-lolly or chewing gum direct postoperative will
have lower pain intensity scores in the 24 hours following surgery compared to
no non-pharmacological treatment.
2) Patients receiving an ice-lolly or chewing gum direct postoperative will
have a reduced analgesic consumption in the 24 hours following surgery compared
to no non-pharmacological treatment.
3) Patients receiving an ice-lolly or chewing gum direct postoperative will
have a lower incidence of PONV and need less anti-emetic drugs in the 24 hours
following surgery compared to no non-pharmacological treatment.*
Study design
Each patient will be randomized to receive either an ice-lolly (n = 50),
chewing gum (n = 50) or no non-pharmacologic treatment (n = 50). The
non-pharmacological treatment will start 15 minutes after the arrival at the
recovery to make sure the patients are awake and able to follow instruction
regarding the intervention.
Ice-lolly: patients will receive an ice-lolly in a taste of their preference.
Chewing-gum: patients will receive chewing gum for 20 minutes
During the interventions a nurse will be present for safety in case patients
are still drowsy from the anesthesia.
Study burden and risks
-
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- either sex
- ASA 1-3
- age 18-75
- planned to undergo elective laparoscopic cholecystectomy
Exclusion criteria
(1) Pain scores > 3 (on a 11-point numerical rating scale, NRS) reported for most of the day during the past month;
(2) Regular use of analgesics for any purpose, including SNRIs, gabapentinoids, COX inhibitors or NSAIDs during the previous month;
(3) The presence of any chronic pain disorder;
(4) The presence of swallowing problems;
(5) Inability to give informed consent;
(6) Inability to communicate with the investigators;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL52085.058.15 |