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Trial registered on ANZCTR


Registration number
ACTRN12615000636550
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
19/06/2015
Date last updated
19/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postoperative analgesia of continuous wound catheters and ultrasound guided rectus sheath catheters for colorectal surgery.
Scientific title
Comparative study between continuous wound catheters and ultrasound guided rectus sheath catheters for postoperative analgesia in patients undergoing elective colorectal surgery.
Secondary ID [1] 286786 0
nil
Universal Trial Number (UTN)
1111-1170-4690
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain following elective open colorectal surgery 295162 0
Condition category
Condition code
Anaesthesiology 295400 295400 0 0
Pain management
Oral and Gastrointestinal 295401 295401 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 295589 295589 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group I: " Wound catheter continuous infusion group (CWCs) 30 patient":
wound catheter was inserted before closure of wound.
Technique:
Two multi-orifice catheters were implanted by the surgeon into the subcutaneous layer on both sides of the surgical incision. The catheters were embedded into the wound to a length of approximately 6 - 10 cm and secured to the skin. A loading dose 10 mL of 0.25% bupivacaine was infused through each catheter just before closure of the incisional site. Analgesia was maintained by infusing 0.25% bupivacaine at a rate of 4 mL/h through two catheters (2 mL/hour per catheter) through electric infusion pump for 48 hours.
Group II: "Rectus Sheath Catheters group (RSCs) 30 patient": Rectus sheath catheters were inserted bilaterally by the aid of ultrasonography at the end of surgery.
Technique:
The upper abdomen was prepared with 2% betadine, then the rectus muscle is imaged with a sheathed ultrasound probe in a longitudinal orientation above the level of the umbilicus. The probe was broadband (5-12MHz), 50 mm foot-print , linear array with an imaging depth of 4-6 cm. At first ultra-sonography probe identified the lina alba, then it was moved laterally to demonstrate the main body of the rectus abdominis muscle and the posterior rectus sheath, then 18G Tuohy needle was introduced few millimeters from the probe using an in plane technique at an angle of approximately 45 degrees to the skin just below the costal margin. The ultrasound allowed identification of the rectus muscle and posterior rectus sheath and fascia transversalis (two hyperechoic railway-like lines deep to it ). The needle tip was advanced to the desired position between the rectus muscle and the underlying posterior rectus sheath then 20 mL bupivacaine 0.25% (loading dose) were injected creating a space for the rectus sheath catheter to be introduced, causing hydro-dissection of the rectus muscle away from the posterior rectus sheath, and 4-8 cm of catheter was left in this space. The catheter depth at the skin is usually 12-15cm. To avoid interference with the surgical field the rest of the catheter was tunneled laterally. The same was repeated on the other side. Analgesia was maintained by injecting 10 ml bupivacaine 0.25% on each side every 6 h in the first 24 h postoperatively then every 12 h in the second 24 h to maintain analgesia. The catheters were removed after 48 hours post-operative.
Intervention code [1] 291941 0
Treatment: Devices
Intervention code [2] 291942 0
Treatment: Drugs
Comparator / control treatment
Group I: " Wound catheter continuous infusion group
Control group
Active

Outcomes
Primary outcome [1] 295147 0
Visual Analogue Pain Scale (VAS) score (0-10) at rest and with activity (movement in bed)
Timepoint [1] 295147 0
at 0, 6, 12, 24, 36 and 48 hours postoperatively.
Primary outcome [2] 295148 0
I.V morphine consumption .
Timepoint [2] 295148 0
If pain score was greater than or equal to 4 the patient received 0.05 mg morphine per kg per dose repeated ( if needed) every 10 minutes up to 0.3 mg kg (maximum dose) for 48 hours post-operative. The time and number of doses and the number of patients in each group were recorded.
Primary outcome [3] 295149 0
Patient satisfaction on a four-point verbal rating scale (1 = extremely unsatisfied, 2 = unsatisfied, 3 = satisfied, and 4 = extremely satisfied).
Timepoint [3] 295149 0
at 24 hours
Secondary outcome [1] 314874 0
Mean arterial blood pressure measured non-invasively.
Timepoint [1] 314874 0
at 0, 6, 12, 24, 36 and 48 hours postoperatively.
Secondary outcome [2] 314875 0
Heart rate through ECG
Timepoint [2] 314875 0
at 0, 6, 12, 24, 36 and 48 hours postoperatively.
Secondary outcome [3] 314876 0
Any undesirable postoperative side effect or complications e.g post-operative ileus, catheter related infection, local anesthetic toxicity .....etc were recorded.
Timepoint [3] 314876 0
from the time of insertion of the catheters till 48 hours postoperatively

Eligibility
Key inclusion criteria
Adult patients of both sexes aged (40-65) years, (ASA) physical state class I and II scheduled for elective open colo-rectal surgery via midline exploratory abdominal incision in the general surgical department, Tanta University Hospital.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they were presented with coagulopathies and impaired platelet functions, cardiovascular instability, cerebral strokes, renal disease or liver disease. Patients with local infection at the site of the block or with history of allergy to local anesthetics were, also excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were randomized preoperatively
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using closed envelops and computer generated random numbers into 2 equal groups each of 30 patients
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size calculation was found to be N > 27 for each study group based on the following criteria; 95% confidence limit, 80% power of the study, ratio of cases to control is 1:1, expected outcome ranging between 70-95%.
The data were analyzed using SPSS (version 20); quantitative data were expressed as mean +/- SD (age, weight, duration of anesthesia, HR and MAP) and analyzed using independent-t-test for comparison between the two groups. F Test was used for comparison within the same group and Tukey's test is used as post hoc test. The non-parametric data (the VAS at rest, VAS at movement and patient satisfaction) which did not follow the normal distribution were analyzed with Mann-Whitney U test for comparison between the two groups and Kruskal Willis H test for comparison within the same group. While, the sex, number of patients who needed supplemental injection, and complications were expressed as (number %). P< 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2014
Actual
29/04/2014
Date of last participant enrolment
Anticipated
27/04/2015
Actual
27/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6898 0
Egypt
State/province [1] 6898 0
Tanta, El Gharbia Governorate

Funding & Sponsors
Funding source category [1] 291334 0
Self funded/Unfunded
Name [1] 291334 0
Hoda Alsaid Ahmed Ezz
Country [1] 291334 0
Egypt
Funding source category [2] 291335 0
Self funded/Unfunded
Name [2] 291335 0
Abd El Raheem M. Dowidar
Country [2] 291335 0
Egypt
Primary sponsor type
Individual
Name
Hoda Alsaid Ahmed Ezz
Address
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country
Egypt
Secondary sponsor category [1] 290014 0
Individual
Name [1] 290014 0
Abd El Raheem M. Dowidar
Address [1] 290014 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country [1] 290014 0
Egypt
Secondary sponsor category [2] 290023 0
Individual
Name [2] 290023 0
Ahmed Abd Elaziz Shama
Address [2] 290023 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country [2] 290023 0
Egypt
Secondary sponsor category [3] 290024 0
Individual
Name [3] 290024 0
Marwa Ahmed Eloraby
Address [3] 290024 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country [3] 290024 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292898 0
The research Ethics Committee of the Faulty of Medicine ,Tanta University, Egypt.
Ethics committee address [1] 292898 0
Ethics committee country [1] 292898 0
Egypt
Date submitted for ethics approval [1] 292898 0
Approval date [1] 292898 0
27/04/2014
Ethics approval number [1] 292898 0
2474/03/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52922 0
A/Prof Hoda Alsaid Ahmed Ezz
Address 52922 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country 52922 0
Egypt
Phone 52922 0
+20 1222768250
Fax 52922 0
Email 52922 0
hodaezz714@yahoo.com
Contact person for public queries
Name 52923 0
Abd El Raheem M. Dowidar
Address 52923 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country 52923 0
Egypt
Phone 52923 0
+20 12223195015
Fax 52923 0
Email 52923 0
dr.dowidar47@hotmail.com
Contact person for scientific queries
Name 52924 0
Abd El Raheem M. Dowidar
Address 52924 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country 52924 0
Egypt
Phone 52924 0
+20 12223195015
Fax 52924 0
Email 52924 0
dr.dowidar47@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePostoperative analgesia of ultrasound guided rectus sheath catheters versus continuous wound catheters for colorectal surgery: A randomized clinical trial.2016https://dx.doi.org/10.1016/j.egja.2016.02.001
N.B. These documents automatically identified may not have been verified by the study sponsor.