NCT00722709

Brief Summary

Aim: The general aim of this research group is to improve the recovery of patients after abdominal surgery. The specific aim of this study is to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia application on postoperative pain and post-operative fatigue. This will be conducted in the setting of an enhanced recovery after surgery program (ERAS). Methods: Patients will be randomised by computer generated random numbers and opaque envelope method. In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9% saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at 4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of postoperative pain will be performed by visual analogue scale, and fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at various intervals post-operatively. Blood tests for inflammatory markers including glucose, cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be taken. Significance to health: This method of analgesia administration has not been investigated in open major colonic surgery. This trial has wide reaching implications, with the potential to improve pain and thus recovery after abdominal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

July 23, 2008

Last Update Submit

January 12, 2010

Conditions

Colon Surgery

Keywords

PainFatigueColonSurgeryERASFastrackLocal anaestheticPeritoneumMetabolicEndocrinePost surgical metabolic responseComplicationsTime to passage of flatusTime to passage of stoolTime to discharge from facilityRe-admission rate

Outcome Measures

Primary Outcomes (1)

  • Post operative recovery using the Identity consequence fatigue scale (ICFS)

    Base-line, Day 1, Day 3, Day 7, Day 14, Day 30, Day 60

Secondary Outcomes (6)

  • Post-operative rest, movement and cough pain using Visual analogue score

    2,4,6,8,12,24,48,72 hours and on day 7

  • Post operative analgesia use using morphine equivalence data

    Total use on day 1, day 2, day 3 post operatively and total use until discharge

  • Serum Ropivacaine level, serum Cytokine, serum Cortisol, serum glucose and serum CRP. Albumin, haematological parameters and biochemical parameters.

    Pre-operatively, 8, 20, 48,72 hours post operatively

  • Questions aimed at symptoms of local anaesthetic toxicity

    2, 4, 6, 8, 12, 24, 48, 72 hours post operatively

  • Recovery of bowel function measured by time to pass flatus and time to pass stool post-operatively.

    Assessed at 2, 4, 6, 8, 12, 24, 36, 48, 60, 72 hours.

  • +1 more secondary outcomes

Study Arms (2)

LA

EXPERIMENTAL

Use of Ropivacaine

Drug: Ropivacaine

Placebo

PLACEBO COMPARATOR

Use of 0.9% saline

Drug: 0.9% Saline

Interventions

RopivacaineDRUG

In the treatment arm patients will receive 10mls 0.75% ropivacaine diluted to 50mls with saline immediately before closure. At closure, two small 2 mm catheters will be placed in the peritoneal cavity at the site of the operation to infuse local anaesthesia. This will penetrate through the skin once closure is complete. This will be attached to a small infusion pump (On-Q pain buster). This pump will contain 270mls of 0.2% ropivacaine. After 68 hours the pump will be stopped and the catheter will be removed in a similar fashion as routine drain removal.

LA
0.9% SalineDRUG

In the placebo arm patients will receive 50 ml 0.9% saline into the peritoneum soon after the creation of the laparotomy. At closure, two 2 mm catheters will be placed in the peritoneal cavity at the site of the operation to infuse local anaesthesia. This will penetrate through the skin once closure is complete. This will be attached to a small infusion pump on-Q pain buster). This pump will contain 0.9% saline. After 68 hours the pump will be stopped and the catheter will be removed in a similar fashion as routine drain removal.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients undergoing open colonic resection at MSC under the ERAS program.

You may not qualify if:

  • Known sensitivity to the local anaesthetic agents
  • Patients who prefer not to participate (no consent gained)
  • ASA greater or equal to 4
  • Rectal resection
  • Formation of stoma
  • Current use of systemic steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manukau Surgery Centre-Middlemore Hospital

Auckland, Auckland, 2240, New Zealand

Location

University of Auckland

Auckland, Auckland, New Zealand

Location

Related Publications (2)

  • MacFater WS, Xia W, Barazanchi AWH, MacFater HS, Lightfoot N, Svirskis D, Kahokehr AA, Hill AG. Association between perioperative intraperitoneal local anaesthetic infusion and long-term survival and cancer recurrence after colectomy: follow-up analysis of a previous randomized controlled trial. ANZ J Surg. 2020 May;90(5):802-806. doi: 10.1111/ans.15753. Epub 2020 Feb 23.

    PMID: 32090464DERIVED

  • 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: 21670611DERIVED

MeSH Terms

Conditions

PainFatigue

Interventions

RopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Arman A Kahokehr, MBChB

    University of Auckland, New Zealand

    STUDY DIRECTOR

  • Andrew G Hill, FRACS

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

NZ(2)