Postoperative analgesia of continuous wound catheters and ultrasound guided rectus sheath catheters for colorectal surgery.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000636550
• Date of registration: 19/06/2015
• Prospective Registration: No
• Primary sponsor: Hoda Alsaid Ahmed Ezz
• 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.
• Date of first enrolment: 29/04/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000636550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Prof Abd El Raheem M. Dowidar

• Name: Prof Abd El Raheem M. Dowidar

Key inclusion & exclusion criteria

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.
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.

Age minimum: 40 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery - Other surgery

Anaesthesiology - Pain management

Post-operative pain following elective open colorectal surgery;
Post-operative pain following elective open colorectal surgery

Intervention(s)

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 posit

Primary Outcome(s)

Patient satisfaction on a four-point verbal rating scale (1 = extremely unsatisfied, 2 = unsatisfied, 3 = satisfied, and 4 = extremely satisfied).[at 24 hours]

Visual Analogue Pain Scale (VAS) score (0-10) at rest and with activity (movement in bed) [at 0, 6, 12, 24, 36 and 48 hours postoperatively.]

I.V morphine consumption .[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.]

Secondary Outcome(s)

Mean arterial blood pressure measured non-invasively. [at 0, 6, 12, 24, 36 and 48 hours postoperatively.]

Heart rate through ECG[at 0, 6, 12, 24, 36 and 48 hours postoperatively.]

Any undesirable postoperative side effect or complications e.g post-operative ileus, catheter related infection, local anesthetic toxicity .....etc were recorded.[from the time of insertion of the catheters till 48 hours postoperatively]

Secondary ID(s)

nil

Source(s) of Monetary Support

Abd El Raheem M. Dowidar

Hoda Alsaid Ahmed Ezz

Secondary Sponsor(s)

Marwa Ahmed Eloraby

Ahmed Abd Elaziz Shama

Abd El Raheem M. Dowidar

Ethics review

Status: Approved
Approval date:
Contact:

The research Ethics Committee of the Faulty of Medicine ,Tanta University, Egypt.