CompletedPhase 4ACTRN12613001159741

Sprayed Peritoneal Regional Analgesia in Appendicectomy trial - SPRAY trial

In children undergoing laparoscopic appendicectomy for acute appendicitis, does local anaesthetic sprayed onto the peritoneum, compared to saline, reduce post-operative pain.


Sponsor

The University of Auckland Department of Surgery

Enrollment

174 participants

Start Date

May 21, 2014

Study Type

Interventional

Conditions

Summary

Context Appendicectomy for acute appendicitis is the most common emergency abdominal operation performed for children. We routinely perform the operation laparoscopically because it is known to reduce pain after surgery; however, post-operative pain can still be severe. We hypothesise that the peritoneum may contribute substantially children's discomfort. Objectives To test the efficacy of peritoneal local anaesthetic on post-operative pain in laparoscopic appendicectomy for acute appendicitis. Methods Children and their caregivers will be invited to participate in a randomized blinded placebo controlled clinical trial on peritoneal local anaesthetic in laparoscopic appendicectomy. After obtaining informed consent for both the laparoscopic procedure and the trial, children will be randomized to receive either local anaesthetic (0.125% bupivacaine) or saline (0.9% sodium chloride) sprayed onto the peritoneum of the right iliac fossa and pelvis. The primary outcome will be pain scores, global pain and also localised pain as measured by a novel pain location tool developed and validated by our unit (the Location and Level of Intensity of Post-operative Pain Score - Lolipops). Benefits Reducing children's pain is patently beneficial. An effect of less pain is lower opiate requirements, benefiting children by avoiding nausea, itch, and other unpleasant side effects. Furthermore, shorter hospital stays and even day case surgery may be possible; the health system could benefit substantially from shorter hospital stays and lower costs.


Eligibility

Sex: Both males and femalesMin Age: 8 YearssMax Age: 15 Yearss

Inclusion Criteria2

  • Acute appendicitis
  • Children aged 8 years and older

Exclusion Criteria6

  • Developmental delay, neuro-muscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness.
  • Unable to speak and read English
  • Partially sighted or blind
  • Presence of any abdominal prostheses such as a gastrostomy or ventriculo-peritoneal shunt
  • Allergy to bupivacaine
  • Consent not obtained from both the participating child and a parent or legal guardian

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Interventions

Peritoneal spray of local anaesthetic, bupivacaine, at a concentration of 0.125%, will be sprayed only the peritoneum of the right iliac fossa and pelvis during laparoscopic surgery for suspected appe

Peritoneal spray of local anaesthetic, bupivacaine, at a concentration of 0.125%, will be sprayed only the peritoneum of the right iliac fossa and pelvis during laparoscopic surgery for suspected appendicitis.


Locations(1)

New Zealand

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ACTRN12613001159741


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