Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

Postoperative Pain Clinical Trial

Official title:

A Randomised Controlled Trial of Thoracic Epidural Analgesia Versus Surgically Placed Rectus Sheath Catheters for Open Radical Cystectomy: Is There a Difference in Patient Outcomes?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02572804
• Other study ID #: V15-02041
• Secondary ID: H1502041
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 31, 2016
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Vancouver Coastal Health
• Contact: Edmund CP Chedgy, MBBS,FRCS
• Phone: +1 604-875-4111
• Email: echedgy[@]prostatecentre.com
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomised controlled trial that will compare the outcomes of rectus sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower midline abdominal incision for bladder cancer.

Description:

This study will compare the outcomes of two different pain control techniques, used as standard of care, following major abdominal surgery for bladder removal. Rectus sheath catheters are small tubes that are positioned into a specific area of the cut abdominal wall at the end of surgery; whereas an epidural is a tube that is positioned into the back. Both allow administration of local anaesthetic for pain control. The current gold standard is an epidural. This study will aim to evaluate this and show the comparative efficacy of the rectus sheath catheter, which anecdotally the investigators have found superior in practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients over or equal to the age of 19 years old who can understand the study protocol and are able to give consent

• Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3

• Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30mg morphine equivalents

• Patients must be able to understand and be able to use patient controlled analgesia

• Patients must be undergoing a cystectomy with an infra-umbilical midline incision

Exclusion Criteria:

• Patients with BMI greater than 40

• Patients with an allergy to local anaesthetics

• Patients who are contraindicated to having an epidural (e.g. coagulopathic, distorted anatomy, patient refusal, infection at the site of proposed insertion)

• Patients with previous spinal surgery at the proposed site of epidural

• Patients with neurodegenerative disorders or spinal cord injury

• Patients with known anatomy that would not permit placement of the rectus sheath catheters e.g. Prune Belly Syndrome

• Patients undergoing another complex abdominal procedure in addition to cystectomy and reconstruction requiring extension of the abdominal incision above the umbilicus.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Pain, Postoperative
• Postoperative Pain
• Urinary Bladder Neoplasms

Intervention

Device:
• Epidural
Patients in this group will have an epidural inserted in a standard fashion, prior to the induction of anesthesia. These will be infused with 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response. Patients will also receive a patient controlled analgesia with hydromorphone 0.2mg/ml, bolus of 200 micrograms with 6 minute lock out (variable in accordance with anesthetic preference).
• Rectus Sheath Catheters
Patients in this group will have surgically inserted rectus sheath catheters (bilaterally), immediately prior to closure of the anterior abdominal wall. These will be infused with 0.125% Bupivicaine at 5mls an hour at a standard rate.Patients will also receive a patient controlled analgesia with hydromorphone 0.2mg/ml, bolus of 200 micrograms with 6 minute lock out (variable in accordance with anesthetic preference).

Locations

Country	Name	City	State
Canada	Vancouver Prostate Centre, Dept. Urologic Sciences	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Vancouver Coastal Health	University of British Columbia, Vancouver Prostate Centre

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. Review. — View Citation

Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-50. doi: 10.1016/j.eururo.2014.11.043. — View Citation

Dutton TJ, McGrath JS, Daugherty MO. Use of rectus sheath catheters for pain relief in patients undergoing major pelvic urological surgery. BJU Int. 2014 Feb;113(2):246-53. doi: 10.1111/bju.12316. — View Citation

Guillotreau J, Gamé X, Mouzin M, Doumerc N, Mallet R, Sallusto F, Malavaud B, Rischmann P. Radical cystectomy for bladder cancer: morbidity of laparoscopic versus open surgery. J Urol. 2009 Feb;181(2):554-9; discussion 559. doi: 10.1016/j.juro.2008.10.011. — View Citation

Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group.. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. — View Citation

Ready LB. Acute pain: lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):499-505. — View Citation

Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group.. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative post-operative opioid consumption		To Day 3 post-op	No
Secondary	Visual Analogue Score pain score		within 4 hours post-operatively and on days 1, 2 and 3 post-operatively	No
Secondary	Patient total intraoperative Opioid requirement	Opioid requirement will be measured in morphine equivalents and reported as such on a per patient basis and measured throughout the operation.	Intraoperatively	No
Secondary	Total patient fluid requirements throughout hospital admission	Measurement of individual patient fluid balance will be performed up to and including day 3 post-operatively.	From the start of the operation to day 3 post-operatively.	No
Secondary	Recorded evidence of hypotension	Hypotension for the purposes of this study is defined as a systolic blood pressure of less than 95.	Until Day 3 postoperatively	No
Secondary	Duration of post-operative ileus	Ileus will be measured by a 3 separate variables - bowel sounds, passing of flatus and opening of bowels. The post-operative day on which each of these targets is achieved for each patient will be recorded.	This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.	No
Secondary	Time to mobilisation		The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively	No
Secondary	Length of Hospital Stay		The day at which patient is discharged from hospital- usually on average 10 days post-operatively	No
Secondary	Patient Satisfaction with pain control	Patient satisfaction with pain control will be measured using a 9-point Likert scale on day 3 post-operatively.	Day 3 post operatively	No
Secondary	Complications and side effects.	At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity.	30 day morbidity and mortality	Yes

External Links

•   European Association of Urology guidelines on reporting post-operative complications