This study will evaluate the addition of a local anaesthetic infusion into the abdomen to patient controlled analgesia in the management of postoperative pain and recovery after bowel surgery. Half of the patients will have an infusion of a local anaesthetic called ropivacaine and half will have an infusion of placebo in addition to their normal pain relief.
The purpose of this randomised controlled blinded trial is to determine the effectiveness in every day practice of intraperitoneal local anaesthetic (IPLA) infusion on postoperative recovery following bowel resection in an optimised Enhanced Recovery After Surgery (ERAS) setting. The investigators hypothesise that, in an optimised ERAS setting, intraperitoneal instillation and infusion of the local anaesthetic ropivacaine to the site of maximal visceral dissection for 48 hrs will result in an improved functional postoperative recovery following both open and laparoscopic bowel surgery. This research will provide evidence to allow recommendation on the routine inclusion of IPLA into the multimodal analgesia component of ERAS programs for bowel surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Intraperitoneal instillation and infusion
Intraperitoneal instillation and infusion
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Change from Baseline of the Surgical Recovery Scale to Day 45
The postoperative domains of recovery of fatigue, and the post-discharge return to normal functioning in both cognition (concentration) and activities of daily living will be assessed using the Surgical Recovery Scale, previously validated for use following bowel surgery.
Time frame: Baseline (preoperative), and postoperative days 1, 3, 7, 30 and 45
Change in Pain Over Time to Day 7 (Subjective)
Postoperative pain at rest and with movement (defined as coughing) will be evaluated using a 100mm Visual Analogue Scale with the end-points labelled "no pain" and "the worst possible pain" for each of: I. somatic pain (incisional pain in the abdominal wall that the patient can touch) II. visceral pain (deep, dull, inside the abdomen) III. shoulder tip pain
Time frame: At postoperative hours 3, 6, 12, 24, 48, and 72, and at day 7
Change in Pain Over Time to day 3 (Objective)
Total opioid analgesia use during the postoperative day 1, 2, and 3 prior to discharge will be recorded and quantified using the Mean Equivalent Daily Dose (MEDD) method. Initially this will be parenteral fentanyl consumption, recorded daily in the patient controlled analgesia (PCA) device until removal of PCA. Then this will be prn tramadol, or other opioid as charted, until discharge. Time to first PCA button press, and the number of PCA button presses will also be recorded as sometimes patients would like more analgesia than the PCA is able to administer.
Time frame: Postoperative day 1, 2, and 3
Recovery of Normal Bowel Function
Time to tolerating oral diet and to first postoperative flatus, and bowel motion will be recorded. Post-operative antiemetic use will be recorded, as will number of episodes of vomiting. The length of time requiring postoperative intravenous fluid will be recorded. The requirement for insertion of naso-gastric tube will be recorded.
Time frame: Inpatient postoperative period (variable), and expected duration of 3-7 days.
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Time to Readiness for Discharge
The time to readiness for discharge (TRD) is a validated measurement of short-term recovery after colorectal surgery. TRD and actual length of stay (LOS) will be recorded. Discharge criteria will be defined as 1. Passage of flatus or bowel motion, tolerance of oral diet and absence of nausea and vomiting. 2. Mobilisation back to baseline function. 3. Analgesia requirement managed with oral tablets only. 4. Willingness to be discharged home. Readmission, defined as unplanned return to hospital within 30 day and requiring an overnight admission, will be recorded. Total hospital stay will be recorded as LOS + readmission LOS.
Time frame: up to 30 days
Operative Complications
All complications that occur within a 30d postoperative period will be recorded. Complications will be recorded and graded using the Clavien-Dindo classification system.
Time frame: 30 days post operation