Intraperitoneal Local Anaesthetic in Bowel Surgery

NCT02449720 | Completed Phase 4

• 1 other identifier: 150219
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Disorders

Keywords

intraperitoneal; ropivacaine; bowel resection; local anaesthetic; recovery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Pain Over Time to Day 7 (Subjective)

  At postoperative hours 3, 6, 12, 24, 48, and 72, and at day 7

• Change in Pain Over Time to day 3 (Objective)

  Postoperative day 1, 2, and 3

• Recovery of Normal Bowel Function

  Inpatient postoperative period (variable), and expected duration of 3-7 days.

• Time to Readiness for Discharge

  up to 30 days

• Operative Complications

  30 days post operation

Study Arms (4)

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.

Drug: Ropivacaine

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.

Drug: 0.9% Saline

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.

Drug: Ropivacaine

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.

Drug: 0.9% Saline

Interventions

Ropivacaine DRUG

Intraperitoneal instillation and infusion

Also known as: Naropin

Laparoscopic Bowel Surgery: IPLA; Open Bowel Surgery: IPLA

0.9% Saline DRUG

Intraperitoneal instillation and infusion

Also known as: Normal Saline

Laparoscopic Bowel Surgery: Control; Open Bowel Surgery: Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study population will include adults from the Central Adelaide Local Health network catchment area, South Australia.
• Patients known to the Colorectal Surgical Unit who have provided informed consent to undergo elective large bowel resection for any indication or undergoing reversal of Hartmann's Procedure will be invited to participate in this study.
• Potential participants will then be provided with an Information Sheet and encouraged to take the time to read it, discuss it with anyone they like, and ask any questions they have prior to deciding if they wish to participate. They will be reassured that participation is voluntary and there is no disadvantage to them if they decide not to participate.

You may not qualify if:

• Under 18 years of age or over age 90.
• Allergy to local anaesthetic.
• Underlying medical conditions requiring deviation from the proposed anaesthetic protocol i.e., use of spinal or epidural anaesthesia rather than general anaesthesia.
• American Society of Anesthesiologists (ASA) \>=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data.
• Severe underlying cardiovascular disease including conduction abnormalities, ischaemic heart disease or congestive heart failure, or use of amiodarone as a regular medication due to a higher risk or cardiac arrest under general anaesthetic or during use of local anaesthesia.
• Chronic Renal Failure (CRF) Stage 3 (GFR \> 60 based on two samples a minimum 90d apart).
• The pharmacokinetics of ropivacaine is not affected by renal failure although the renal clearance of its main metabolite (S)-2',6'-pipecoloxylidide (PPX) correlates with creatinine clearance, non-renal clearance compensates for reduced renal clearance in most patients.
• GFR will be calculated using the Cockcroft Gault equation for creatinine clearance (CrCl) : CrCl ml/min = \[140-age(years)\] x bodyweight (kg) / R x serum creatinine (micromol/L)
• R = 0.815 for males, 0.85 for females
• Hepatic dysfunction of Child-Pugh class B or C. Patients with end-stage liver disease have about a 60% lower mean ropivacaine clearance than healthy subjects and are thus expected to have over two-fold higher steady-state ropivacaine plasma concentrations during a continuous ropivacaine infusion.
• Concurrent or recent (within 3 months) use of fluvoxamine, enoxacin, ketoconazole, or cimetidine. These are potent CYP (cytochrome P450) 1A2, 2E1, or 3A4 inhibitors that have been shown to reduce ropivacaine clearance in vivo or in in vitro models. Potential participants concurrently using other potent CYP1A2, 2E1, or 3A4 inhibitors, where it is unclear if there is an effect on ropivacaine clearance, will be included or excluded from the study at the discretion of their study specialist anaesthetist.
• Abdominal-perineal resections (APR) due to the greater area of dissection and skin incision which will increase the level of baseline somatic pain felt by a patient.
• Requirement for postoperative drain in-situ, as this will drain the experimental solution out of the abdomen.
• Preoperative systemic steroid dependence due to derangement of the inflammatory response.
• Preoperative chronic pain illness including fibromyalgia, chronic regional pain syndrome, chronic fatigue syndrome, non specific chronic pain requiring daily opiate use, and history of alcohol or drug dependence due to the impact these have on subjective interpretation of pain and tolerance to opioid requiring significantly higher dosing regimens.

Sponsors & Collaborators

• Royal Adelaide Hospital: lead
• University of Adelaide: collaborator
• University of South Australia: collaborator
• Saint Andrew's Hospital: collaborator
• Calvary North Adelaide Hospital: collaborator

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 4000, Australia

Location

Related Publications (3)

• 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.

  PMID: 21392804 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.

  PMID: 21670611 RESULT

• 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.

  PMID: 30192329 DERIVED

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jaime A Duffield, BMBS PhD

  Royal Adelaide Hospital, Colorectal Surgical Unit Research Registrar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Surgical Unit Research Registrar

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 20, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

AU (1)