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| Name | Class |
|---|---|
| University of Adelaide | OTHER |
| University of South Australia | OTHER |
| Saint Andrew's Hospital | UNKNOWN |
| Calvary North Adelaide Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Bowel Surgery: IPLA | Active Comparator | Participants will undergo laparoscopic bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of IPLA (0.2% Ropivacaine) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of IPLA (0.2% Ropivacaine, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption. |
|
| Laparoscopic Bowel Surgery: Control | Placebo Comparator | Participants will undergo laparoscopic bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of Control (0.9% Saline, 20mg/hr) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of Control (0.9% Saline, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption. |
|
| Open Bowel Surgery: IPLA | Active Comparator | Participants will undergo open bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of IPLA (0.2% Ropivacaine) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of IPLA (0.2% Ropivacaine, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Intraperitoneal instillation and infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperative), and postoperative days 1, 3, 7, 30 and 45 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime A Duffield, BMBS PhD | Royal Adelaide Hospital, Colorectal Surgical Unit Research Registrar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 4000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21392804 | Result | Paddison JS, Sammour T, Kahokehr A, Zargar-Shoshtari K, Hill AG. Development and validation of the Surgical Recovery Scale (SRS). J Surg Res. 2011 May 15;167(2):e85-91. doi: 10.1016/j.jss.2010.12.043. Epub 2011 Jan 31. | |
| 21670611 | Result | Kahokehr A, Sammour T, Zargar Shoshtari K, Taylor M, Hill AG. Intraperitoneal local anesthetic improves recovery after colon resection: a double-blinded randomized controlled trial. Ann Surg. 2011 Jul;254(1):28-38. doi: 10.1097/SLA.0b013e318221f0cf. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| UNKNOWN |
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|
| Open Bowel Surgery: Control | Placebo Comparator | Participants will undergo open bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of Control (0.9% Saline, 20mg/hr) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of Control (0.9% Saline, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption. |
|
| 0.9% Saline | Drug | Intraperitoneal instillation and infusion |
|
|
| 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. | 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. | Inpatient postoperative period (variable), and expected duration of 3-7 days. |
| 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
Total hospital stay will be recorded as LOS + readmission LOS. | 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. | 30 days post operation |
| 30192329 | Derived | Duffield JA, Thomas ML, Moore JW, Hunter RA, Wood C, Gentili S, Lewis M. Intraperitoneal Local Anesthetic Instillation and Postoperative Infusion Improves Functional Recovery Following Colectomy: A Randomized Controlled Trial. Dis Colon Rectum. 2018 Oct;61(10):1205-1216. doi: 10.1097/DCR.0000000000001177. |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |