Pre-Operative Single Shot Rectus Sheath Block

NCT03458598 | Completed

• 1 other identifier: Pro00078459
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives The primary objective is to demonstrate that in patients undergoing major urologic surgery, Patient Controlled Analgesia (PCA) opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had a single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block. Secondary outcomes will be opioid requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including maximum pain score in Post Anesthesia Care Unit (PACU) and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation score, time to first bowel movement, time to first mobilization and duration of hospital stay.

Conditions

Bladder Neoplasm; Prostate Neoplasm; Pelvic Neoplasm; Urologic Neoplasms; Opioid Use; Anesthesia, Local; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Opioid requirement in first 24 hours after surgery

  Opioid requirement in first 24 hours after surgery

  24 hours

Secondary Outcomes (9)

• Intra-operative opioid requirement

  3 - 6 hours

• (Numerical Rating Scale) NRS pain score at 24 and 48 hours

  48 hours

• Severity of Nausea

  48 hours

• Number of vomiting episodes

  48 hours

• Use of anti-emetics

  48 hours

Study Arms (2)

Single shot rectus sheath block

EXPERIMENTAL

The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.

Procedure: Rectus sheath block; Procedure: Bilateral rectus sheath catheter; Drug: Patient controlled opioid analgesia (PCA)

Placebo Control

SHAM COMPARATOR

The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.

Procedure: Bilateral rectus sheath catheter; Drug: Patient controlled opioid analgesia (PCA); Procedure: Subcutaneous injection saline placebo

Interventions

Rectus sheath block PROCEDURE

Rectus sheath block under ultrasound

Single shot rectus sheath block

Bilateral rectus sheath catheter PROCEDURE

A nerve block catheter known as a continuous rectus sheath block is inserted by the surgeon at the end of the operation. An infusion of 0.2% ropivacaine is delivered through this for up to 48 hours post-operatively.

Placebo Control; Single shot rectus sheath block

Patient controlled opioid analgesia (PCA) DRUG

Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.

Placebo Control; Single shot rectus sheath block

Subcutaneous injection saline placebo PROCEDURE

Subcutaneous injection of 1ml of normal saline under ultrasound guidance at the same site bilaterally as rectus sheath blockade is performed

Placebo Control

Eligibility Criteria

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

You may qualify if:

• Adult patients over 18 years
• Undergoing major urological surgery
• Consent to a rectus sheath blockade as part of their postoperative management

You may not qualify if:

• Patients under 18 years
• Local or systemic infection
• Patients who refuse consent
• Opioid tolerance
• History of chronic pain
• Psychiatric illness
• Allergy to local anesthetic.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (5)

• Tsui BC, Green JS, Ip VH. Ultrasound-guided rectus sheath catheter placement. Anaesthesia. 2014 Oct;69(10):1174-5. doi: 10.1111/anae.12849. No abstract available.

  PMID: 25204242 BACKGROUND

• Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

  PMID: 19020158 BACKGROUND

• Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

  PMID: 21296242 BACKGROUND

• 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. Epub 2013 Aug 13.

  PMID: 23937574 BACKGROUND

• Tudor EC, Yang W, Brown R, Mackey PM. Rectus sheath catheters provide equivalent analgesia to epidurals following laparotomy for colorectal surgery. Ann R Coll Surg Engl. 2015 Oct;97(7):530-3. doi: 10.1308/rcsann.2015.0018.

  PMID: 26414363 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Neoplasms; Pelvic Neoplasms; Urologic Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The intra-operative anesthesiologist, surgeon and outcomes assessor are blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 8, 2018
• Study Start: February 16, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)