Postoperative Pain Clinical Trial
— TACSOfficial title:
A Randomized Blinded Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function After Colorectal Surgery
Two key requirements for discharge from hospital after major abdominal surgery are adequate
oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed
discharge after abdominal surgery due to delayed return of gut function, manifesting as
nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are
the mainstay of postoperative analgesic regimens after abdominal surgery and are highly
effective in achieving adequate pain control. However, opioids cause impaired gut function
by reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers
such as Alvimopan counteract these effects and can accelerate postoperative gut recovery but
are expensive and cause cardiac complications; alternative painkillers such as non-steroidal
anti-inflammatories are less effective than opioids and have been linked with increased risk
of anastomotic leaks.
Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride)
and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product
confines the naloxone action to the gut to reduce the unwanted side-effects on gut function.
Targinact has been shown in patients with chronic severe pain to provide comparable
analgesia to other opioid analgesics whilst reducing the unwanted side-effect of
constipation.
The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia
after colonic resection with reduced postoperative gastrointestinal dysfunction. The
surgical procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a
consistently reproducible intervention with a postoperative gut dysfunction rate of up to
40% (prospective data from the Edinburgh Colorectal Unit). The main outcome of the study
will be return of normal gut function at the time of planned discharge (Day 3).
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients scheduled for elective laparoscopic segmental colectomy at the Colorectal Surgery Unit, Western General Hospital, Edinburgh. Exclusion Criteria: - Pregnancy Age <18 years Patients lacking capacity to give informed consent. Severe liver dysfunction (Child's A or greater) Patients participating in another therapeutic clinical trial Contraindication to oxycodone, naloxone or Targinact Pre-existing dependence on opioid analgesia (current medications will be checked prior to discussing consent) Pre-existing use of opioid analgesia for chronic pain (current medications will be checked prior to discussing consent) Patients with rectal cancer Plan to form any stoma during procedure |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Western General Hospital | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Hendry PO, Hausel J, Nygren J, Lassen K, Dejong CH, Ljungqvist O, Fearon KC; Enhanced Recovery After Surgery Study Group. Determinants of outcome after colorectal resection within an enhanced recovery programme. Br J Surg. 2009 Feb;96(2):197-205. doi: 10.1002/bjs.6445. — View Citation
Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170. Review. — View Citation
Simpson K, Leyendecker P, Hopp M, Müller-Lissner S, Löwenstein O, De Andrés J, Troy Ferrarons J, Bosse B, Krain B, Nichols T, Kremers W, Reimer K. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin. 2008 Dec;24(12):3503-12. doi: 10.1185/03007990802584454 . — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of postoperative gut dysfunction | 25% reduction in the proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation. | Day 3 post-op | No |
Secondary | Pain control | Total quantity of Morphine used over standard analgesia protocol | Participants will be followed for the duration of hospital stay, an expected average of 5 days | No |
Secondary | Oral analgesia use | Total dose of oral Oxycodone or Targinact until discontinued by the participant/discharged from hospital | Participants will be followed for the duration of hospital stay, an expected average of 5 days | No |
Secondary | Pain scores | Pain scores measured daily using Overall Benefit of Analgesia Score (OBAS) | Participants will be followed for the duration of hospital stay, an expected average of 5 days | No |
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