Post Operative Analgesia Clinical Trial
Official title:
Postoperative Pain Control Using Continuous Infusion of Levobupivacaine in Women Undergoing Pelvic Operative Laparoscopy: A Randomised Controlled Trial
This study is a blinded randomised study of slow release levobupivacaine vs saline for women undergoing day case operative pelvic laparoscopy. Participants will be randomly given either saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and rescue oral analgesia use.
METHOD:
This is a triple-blinded randomised control study to determine whether a continuous
intraperitoneal infusion of levobupivacaine 0.5%, when compared with normal saline 0.9%, in
women undergoing laparoscopic pelvic surgery as day-case, provides effective postoperative
analgesia.
Primary outcome measure:
• Need for 'rescue' analgesia
Secondary outcome measures:
- Pain intensity (on movement and rest)
- Side effects from rescue analgesia
- Hospital length of stay
- Patient satisfaction with pain relief
Sample:
All women undergoing pelvic laparoscopic surgery as a day-case will be invited to take part
in the study. Women will be excluded if they are undergoing surgery for cancer.
At the pre-operative admission clinic women will receive written information explaining the
trial and inviting them to take part. If they agree to take part, written consent will be
obtained on the morning that they arrive in the day ward for the laparoscopic procedure. At
the end of the intended laparoscopic procedure, the peritoneal cavity will be irrigated with
normal saline and then all the irrigation fluid will be removed through suction. The
multihole catheter will then be inserted percutaneously into the surgical area although it
will not be fixed into place. The catheter will be guided into place with the grasper or
irrigator so that the holed portion of the catheter is in the intended area for anaesthetic
infusion. The catheter will then be kept in place using a steri-strip to skin. Finally, the
laparoscopic trocar sites will be closed in the usual way. Women will be randomised to
receive either normal saline 0.9% or levobupivicaine 0.5%. Patients will be randomised at
the start of the procedure so that the infusion can be prepared in time to be started at the
end of the procedure. Randomisation will be undertaken using computer-generated random
numbers, which will be held off site. The syringes and reservoir bladders Page 2 of 5
Version no. - 2 12.10.08
will be consecutively numbered and randomly filled with either levobupivacaine or normal
saline using block randomisation in blocks of 10 to ensure equal number in each group. This
will ensure that the surgeons, the anaesthetist and the patient will be blinded to the
treatment group. In the event of an untoward incident the code will be broken, a sealed list
being kept on the labour ward cupboard where it will be available 24 hours a day . At the
end of the surgical procedure, a bolus of 5mls of the infusion will be delivered via the
catheter, following which the rate is set at 2ml per hour. Patients will be discharged home
in the usual way but will continue with the infusion for a total of 48 hours. Appropriate
training will be in place for the participants and a leaflet will be given to them for
support which will provide them with written instructions about the infusion device, how to
care for it and how to remove it after the 48 hour period. They will also be provided with a
telephone contact in case of any concerns about the infusion. Women who do not feel
confident in removing the catheter at home will be requested to attend the gynaecology ward
to have it removed by the gynaecology senior house officer. The participants will be
provided with emergency contact telephone numbers if there are any concerns.
Power Calculation:
The sample size has been calculated based on the results of the randomised controlled study
of bupivicaine versus normal saline in women undergoing an abdominal hysterectomy (Gupta et
al 2004). In Gupta's study, the bupivicaine group used a total of 30.5mg (SD 15.4) of
ketobemidone in the first 24 hours postoperatively. This compares to the placebo group, who
used 44.3mg (SD 21.6); a clinically significant difference of approximately 30% reduction in
pain in the treatment group.
Assuming an alpha of 0.05, we require a total of 52 patients (26 in each arm) to achieve a
power of 90% (Beta = 0.1).
Page 3 of 5 Version no. - 2 12.10.08
Data collection:
All information relating to postoperative pain will be collected in a specifically designed
pain measurement booklet. This will be completed whilst in hospital and then taken home with
the patient for completion in the remaining 48 hours following surgery. The pages relating
to pain measures experienced in hospital will be recorded on duplicate paper so that one
copy can be retained in the medical records. Patients will be provided with a stamped
addressed envelope for returning the pain measurement booklet.
Data to be collected:
All analgesia used will be recorded by amount and time taken. Pain will be measured at rest
and on movement (walking and coughing) using a 10-point scale and will be taken at 1, 2, 3
and 4 hours. Thereafter the participants will be requested to record the pain intensity on
the evening of the operation, morning-after the operation, afternoon on the following day,
evening on the following day and on the second day after the operation i.e. 48 hours
postoperatively. Time 0 will be taken to represent the time the infusion was started. Nausea
will be measured on a 10-point scale and will be taken at for the 48 hour period while
recording the pain intensity. Hospital length of stay will be recorded in hours and charted
on the pain measurement booklet. Patient satisfaction will also be recorded as less than
satisfied; satisfied; good or excellent. All patients will be contacted by telephone 48
hours postoperatively to enquire about their experiences of using the infusion device and to
request them to return the pain measurement booklet.
Data Analysis:
Significance will be at the p=0.05 or less. SPSS software will be used to undertake the
analysis under the supervision of Mr. Robert Hills.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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