Differences in pain relief after open or laparoscopic colorectal cancer surgery with epidural or intravenous medication

ISRCTN	ISRCTN11426678
DOI	https://doi.org/10.1186/ISRCTN11426678
Secondary identifying numbers	METC 17-4-010

Submission date: 15/02/2021
Registration date: 26/02/2021
Last edited: 04/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
During the years 2013 - 2016 for colonic cancer the standard operating technique in our hospital changed from mainly open to laparoscopic (keyhole surgery) and therefore also the choice of pain relief used during and after the surgery might have changed. We choose to study the period between 2014 and 2016 to evaluate this change in pain treatment and the possible consequences, in addition to changed operating technique, for all patients admitted with this pathology. We tried to answer questions regarding pain treatment, length of stay, complications and 5-year survival.

Who can participate?
All patients scheduled for colonic cancer surgery in an academic tertiary hospital during the years 2014 till 2016.

What does the study involve?
Records were reviewed. The primary outcome of our study was the difference of pain in patients receiving open or laparoscopic interventions with either thoracic epidural (TEA) or intravenous opioid pain (PCIA) relief management. Because it was an observational study there were no benefits or risks for the participants. The study was performed in Maastricht, The Netherlands.
Data collection was prospectively recorded in two different data collection systems. Prospective collected data from the Dutch Surgical Colorectal Audit database (DSCA) were combined with prospective collected data from the acute pain service (APS) and the anesthesia registration system. Data analysis started after approval from the medical ethic committee.

What are the possible benefits and risks of participating?
None (retrospective study)

Where is the study run from?
Maastricht University Medical Centre

When is the study starting and how long is it expected to run for?
January 2017 to June 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
P.B.W. Cox, b.cox@mumc.nl

Contact information

Mr Boris Cox
Scientific

P. Debyelaan 25
Postbus 5800
Maastricht
6202AZ
Netherlands

ORCID ID	0000-0001-5906-3792
Phone	+31 615064074
Email	b.cox@mumc.nl

Study information

Study design	Single centre retrospective observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	No participant information sheet available
Scientific title	Thoracic epidural analgesia versus patient-controlled intravenous analgesia for patients undergoing open or laparoscopic colorectal cancer surgery, an observational study
Study objectives	The goal was to evaluate the postoperative analgesic effectiveness of TEA compared to patient controlled intravenous analgesia (PCIA) after open and laparoscopic colorectal surgery, and to verify if the implementation of TEA leads to enhanced recovery.
Ethics approval(s)	Approved 25/10/2017, Medical Ethics Committee Maastrict UMC+ (P.Debyelaan 25, postbus 5800, 6202 AZ Maastricht, The Netherlands; +31 433876009; secretariaat.metc@mumc.nl), ref: METC 17-4-010
Health condition(s) or problem(s) studied	Analgesia approaches for laparoscopic surgery
Intervention	The study was performed in patients scheduled for laparoscopic or open colonic resections with either thoracic epidural (TEA) or intravenous opioid pain (PCIA) relief management. Data collection was prospectively recorded in two different data collection systems. Data from the Dutch Surgical Colorectal Audit database (DSCA) were combined with prospective collected data from the acute pain service (APS) and the anesthesia registration system. An observational study was performed measuring postoperative pain, LOS, the incidence of epidural side effects, major complications and 5-year survival rate.
Intervention type	Procedure/Surgery
Primary outcome measure	Postoperative pain measured using the NRS postoperatively and at day 1, 2 and 3, both at rest and during movement
Secondary outcome measures	1. Length of stay (days) measured using patient records 2. Incidence of epidural related side effects measured by clinical observation postoperatively at day 1, 2 and 3 3. Major complications measured using patient records for 30 days after surgery 4. 5-year survival measured using patient records
Overall study start date	17/01/2017
Completion date	01/06/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	422
Total final enrolment	422
Key inclusion criteria	All adult patients who underwent colorectal cancer surgery between 2014 and 2016, with ASA status I-IV were included
Key exclusion criteria	1. No postoperative thoracic epidural analgesia of patient controlled analgesia 2. Double cases 3. Missing data
Date of first enrolment	27/10/2017
Date of final enrolment	01/06/2020

Locations

Countries of recruitment

Netherlands

Study participating centre

Maastricht University Medical Centre

P. Debyelaan 25
Maastricht
6202 AZ
Netherlands

Sponsor information

Maastricht University Medical Centre
Hospital/treatment centre

P. Debyelaan 25
Maastricht
6202AZ
Netherlands

Phone	+31 433876543
Email	wolfgang.buhre@mumc.com
Website	http://www.mumc.nl/en
"ROR"	https://ror.org/02d9ce178

Funders

Funder type

Other

investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/10/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The aim is to publish this study in the European Journal of Anaesthesiology.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		04/01/2023	04/03/2025	Yes	No

Editorial Notes

04/03/2025: Publication reference added.
26/02/2021: Trial’s existence confirmed by Maastrict UMC+