NCT03252561

Brief Summary

Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence of nausea, vomiting and sedation which can complicate post-operative recovery. Different techniques of intraoperative infiltration of local anaesthetic to control postoperative pain are also being used. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital discharge. The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in the investigator's hospital.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

Same day

First QC Date

April 20, 2015

Last Update Submit

June 12, 2020

Conditions

Acute Appendicitis

Keywords

TAP blockAcute AppendicitisPost-operative analgesia

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption in the first 12 hours after the operation

    The primary endpoint will be consumption of morphine or other opioids (including tramadol) in the first 12 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios.

    12 hours

Secondary Outcomes (5)

  • Numerical rating pain scores at emergence, 6, 12, 24 hours postoperatively

    24 hours after the operation

  • Time to first request for rescue analgesia

    24 hours after the operation

  • Nausea score at emergence, 6, 12, 24 hours postoperatively

    24 hours after the operation

  • Total length of hospital stay

    After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected length of 1-5 days

  • Opioid consumption at 24 hours

    24 hours after the operation

Study Arms (2)

TAP block

EXPERIMENTAL

Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

Procedure: Ultrasound guided Transversus Abdominis Plane (TAP) bock

Local anaesthetic infiltration

ACTIVE COMPARATOR

Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Procedure: Local anaesthetic infiltration of laparoscopic port sites

Interventions

Ultrasound guided Transversus Abdominis Plane (TAP) bockPROCEDURE

Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

TAP block
Local anaesthetic infiltration of laparoscopic port sitesPROCEDURE

Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Local anaesthetic infiltration

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants willing and able to give informed consent for participation in the study
  • Male or Female, aged 16 years or above
  • Undergoing laparoscopic appendicectomy for a clinical diagnosis of appendicitis
  • American Society of Anaesthetists physical status (ASA) 1-3

You may not qualify if:

  • Opioid tolerance
  • Chronic abdominal pain
  • Allergy/Intolerance: Morphine, local anaesthetics, tramadol
  • BMI (Body Mass Index) \>35 Kg/M2
  • Previous major abdominal surgery
  • High likelihood of conversion of open procedure
  • Patients unable to communicate in written and spoken English
  • Weight less than 50 kg
  • ASA \> 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (3)

  • Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

    PMID: 19561014BACKGROUND

  • Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.

    PMID: 21504934BACKGROUND

  • McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

    PMID: 17961838BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Michael Silva, MBBS,MD,FRCS

    Consultant Upper G Surgeon

    PRINCIPAL INVESTIGATOR

  • Nicholas Crabtree, MBChB,FRCA

    Consultant Anaesthetist

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

August 17, 2017

Study Start

August 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

GB(1)