CompletedPhase 4ACTRN12609000128291

Randomised double blind placebo controlled trial on the effect of intraperitoneal ropivacaine on postoperative pain and recovery after diagnostic laparoscopy and hysteroscopy.

Randomised double blind placebo controlled trial on the effect of intraperitoneal ropivacaine on postoperative pain and recovery after day case gynaecological diagnostic laparoscopy and hysteroscopy.


Sponsor

Dr Natasha Frawley

Enrollment

60 participants

Start Date

Jun 1, 2009

Study Type

Interventional

Conditions

Summary

BRIEF SUMMARY: Laparoscopy and hysteroscopy is a common day case gynaecological procedure. This operation involves keyhole surgery, inserting a small telescope-like device or fibreoptic lens into the abdomen via a 10mm port. This enables direct visualisation of inside the abdomen. There is also one other cut on the abdomen of 5mm, where a thin metal probe is inserted. Finally, a second fibreoptic device, is inserted inside the womb via the vagina and cervix, and the inside of the womb is visualised. A scraping of the womb tissue is taken and sent to the pathology laboratory to be analysed under a microscope. Patients usually go home the same day, unless there have been complications. Pain relief for this procedure has not been studied in any recent large trials. Current pain management involves use of pain relief tablets after the operation, and intravenous analgesics during the operation, including ropivacaine, depending on the anaesthetist. We aim to evaluate the use of intraperitoneal Ropivacaine. This is a local anaesthetic medication that can be squirted inside the abdomen at the areas that have been manipulated including the womb and fallopian tubes and injected at port sites, which are the two small incisions on the abdomen. HYPOTHESIS: We hypothesise that the use of ropivacaine at the end of the procedure will reduce post operative pain and hasten recovery after a diagnostic laparoscopy and hysteroscopy.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • Two port diagnostic laparoscopy and hysteroscopy for any gynaecological reason, age 18-50 years.

Exclusion Criteria9

  • Age <18 years or >50 years,
  • non-English speaking
  • weight <50kg
  • patient refusal
  • operative laparoscopy, laparoscopic sterilization
  • pregnancy
  • rd port required intraoperatively
  • use of regular narcotic analgesia for pain preoperatively
  • contraindications or allergies to any drugs used in the study (including renal disease, diabetes, Non-Steroidal Anti Inflammatory Drug (NSAID) sensitive asthma)

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Interventions

The intervention is using the local anaesthetic, ropivacaine, intraperitoneally, at the end of the diagnostic hysteroscopy and laparoscopy. The dose used is 20mls of 0.25% (100mg) of ropivacaine. It w

The intervention is using the local anaesthetic, ropivacaine, intraperitoneally, at the end of the diagnostic hysteroscopy and laparoscopy. The dose used is 20mls of 0.25% (100mg) of ropivacaine. It will take less than two minutes to administer. The intervention treatment will only be administered once.


Locations(1)

Australia

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ACTRN12609000128291