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A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery (TACS)

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ClinicalTrials.gov Identifier: NCT02109640
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Postoperative Pain
Postoperative Nausea and Vomiting
Interventions Drug: Targinact
Drug: Oxycodone
Procedure: Laparoscopic segmental colectomy
Enrollment 50
Recruitment Details  
Pre-assignment Details 62 patients consented to study participation but 12 were not assigned to the study. This was because consent was obtained a few weeks before the date of surgery and in that interval 12 patients became ineligible (change of planned operation, presentation as emergency, development of ineligibility criteria, withdrawn from anaesthetic protocol).
Arm/Group Title Targinact Oxycodone
Hide Arm/Group Description

Oral Targinact 10-20mg bd following laparoscopic segmental colectomy

Targinact: Post-operative analgesia

Laparoscopic segmental colectomy

Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy

Oxycodone: Postoperative analgesia

Laparoscopic segmental colectomy

Period Title: Overall Study
Started 27 23
Completed 27 23
Not Completed 0 0
Arm/Group Title Targinact Oxycodone Total
Hide Arm/Group Description

Oral Targinact 10-20mg bd following laparoscopic segmental colectomy

Targinact: Post-operative analgesia

Laparoscopic segmental colectomy

Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy

Oxycodone: Postoperative analgesia

Laparoscopic segmental colectomy

Total of all reporting groups
Overall Number of Baseline Participants 27 23 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  25.9%
6
  26.1%
13
  26.0%
>=65 years
20
  74.1%
17
  73.9%
37
  74.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
Female
12
  44.4%
12
  52.2%
24
  48.0%
Male
15
  55.6%
11
  47.8%
26
  52.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
27
 100.0%
23
 100.0%
50
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Prevalence of Postoperative Gut Dysfunction
Hide Description 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.
Time Frame Day 3 post-op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targinact Oxycodone
Hide Arm/Group Description:

Oral Targinact 10-20mg bd following laparoscopic segmental colectomy

Targinact: Post-operative analgesia

Laparoscopic segmental colectomy

Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy

Oxycodone: Postoperative analgesia

Laparoscopic segmental colectomy

Overall Number of Participants Analyzed 27 23
Measure Type: Count of Participants
Unit of Measure: Participants
13
  48.1%
15
  65.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Targinact, Oxycodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments Absolute % difference 17.1 (95% CI -10.0,40.7)
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute percentage difference
Estimated Value 17.1
Confidence Interval (2-Sided) 95%
-10.0 to 40.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Total Opioid Analgesia Consumption
Hide Description Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant
Time Frame Total postoperative period of analgesic consumption, an average of 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targinact Oxycodone
Hide Arm/Group Description:

Oral Targinact 10-20mg bd following laparoscopic segmental colectomy

Targinact: Post-operative analgesia

Laparoscopic segmental colectomy

Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy

Oxycodone: Postoperative analgesia

Laparoscopic segmental colectomy

Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: milligram morphine equivalents
78  (36) 94  (56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Targinact, Oxycodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.222
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Pain Scores
Hide Description

Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:

  • Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain
  • Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)
  • Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)
  • Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)
  • Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)
  • Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)
  • How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511–18 (2010)
Time Frame Postoperative day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targinact Oxycodone
Hide Arm/Group Description:

Oral Targinact 10-20mg bd following laparoscopic segmental colectomy

Targinact: Post-operative analgesia

Laparoscopic segmental colectomy

Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy

Oxycodone: Postoperative analgesia

Laparoscopic segmental colectomy

Overall Number of Participants Analyzed 27 23
Median (Full Range)
Unit of Measure: units on a scale
2
(0 to 10)
2
(0 to 11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Targinact, Oxycodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 30 days postoperative
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Targinact Oxycodone
Hide Arm/Group Description

Oral Targinact 10-20mg bd following laparoscopic segmental colectomy

Targinact: Post-operative analgesia

Laparoscopic segmental colectomy

Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy

Oxycodone: Postoperative analgesia

Laparoscopic segmental colectomy

All-Cause Mortality
Targinact Oxycodone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Targinact Oxycodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/27 (7.41%)      0/23 (0.00%)    
Gastrointestinal disorders     
Anastomotic leak   1/27 (3.70%)  1 0/23 (0.00%)  0
Intraabdominal fluid collection   1/27 (3.70%)  1 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Targinact Oxycodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/27 (70.37%)      18/23 (78.26%)    
Cardiac disorders     
Hypotension  [1]  11/27 (40.74%)  11 11/23 (47.83%)  11
General disorders     
Wound healing   4/27 (14.81%)  4 3/23 (13.04%)  3
Renal and urinary disorders     
Acute urinary retention   4/27 (14.81%)  4 1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxaemia postop   3/27 (11.11%)  3 3/23 (13.04%)  3
Indicates events were collected by systematic assessment
[1]
Self-limiting postop
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Hugh M Paterson
Organization: University of Edinburgh
Phone: 44 131 537 1000
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02109640     History of Changes
Other Study ID Numbers: 2013-005327-16
First Submitted: April 3, 2014
First Posted: April 10, 2014
Results First Submitted: November 23, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017