TQL-block for Laparoscopic Hemicolectomy

NCT03570541 | Completed Phase 4 DMC

• 2 other identifiers: SJ-6632017-005200-96
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia. An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore. Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen. The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.

Conditions

Postoperative Pain

Keywords

Colon cancer; nerve block; ultra-sound; opioids; surgical stress

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Data from PCA pump and patient medical record

  Twenty-four hours postoperative

Secondary Outcomes (38)

• Pain during mobilisation

  Registered upon arrival at the postanaesthesia care unit (PACU) and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.

• Pain at rest

  Registered upon arrival at the PACU and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.

• An integrated assessment of longitudinally measured pain intensity and opioid consumption

  0-24 hours postoperative

• Morphine consumption

  At 6, 12, 18 postoperative hours.

• Duration of block

  Time to first opioid within the first 24 postoperative hours

Other Outcomes (4)

• Cytokines in LPS stimulated blood

  Blood samples are taken preoperatively and day one post surgery

• Cytokines in CD3+CD28 stimulated blood

  Blood samples are taken preoperatively and day one post surgery

• Cytokines in Poly I:P stimulated blood

  Blood samples are taken preoperatively and day one post surgery

Study Arms (2)

Active

ACTIVE COMPARATOR

Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot. Every six hours postoperative, all patients are administered 1 g of acetaminophen. In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment. On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis. On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire. Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.

Drug: Ropivacaine; Drug: Acetaminophen; Device: Patient controlled analgesia; Drug: Morphine; Diagnostic Test: Blood samples; Behavioral: Quality of recovery-15 questionaire; Diagnostic Test: Orthostatic hypotension

Placebo

PLACEBO COMPARATOR

Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot. Every six hours postoperative, all patients are administered 1 g of acetaminophen. In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment. On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis. On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire. Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.

Drug: Acetaminophen; Device: Patient controlled analgesia; Drug: Morphine; Drug: Saline; Diagnostic Test: Blood samples; Behavioral: Quality of recovery-15 questionaire; Diagnostic Test: Orthostatic hypotension

Interventions

Ropivacaine DRUG

30 mL ropivacaine 0,375% administered on each side as bilateral TQL blocks

Active

Acetaminophen DRUG

Every six hours postoperative, all patients are administered 1 g of acetaminophen.

Active; Placebo

Patient controlled analgesia DEVICE

PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.

Active; Placebo

Morphine DRUG

intravenously administered morphine via PCA-pump

Active; Placebo

Saline DRUG

30 ml saline 0,375% administered on each side as bilateral TQL blocks

Placebo

Blood samples DIAGNOSTIC_TEST

On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis

Active; Placebo

Quality of recovery-15 questionaire BEHAVIORAL

On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire.

Active; Placebo

Orthostatic hypotension DIAGNOSTIC_TEST

Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.

Active; Placebo

Eligibility Criteria

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

You may qualify if:

• Age \> 18
• Scheduled for laparoscopic or robot assisted hemicolectomy or sigmoidectomy due to colon cancer
• Have received thorough information, oral and written, and signed the "Informed Consent" form on participation in the trial
• American Society of Anaesthesiologist physical status classification, class 1-3

You may not qualify if:

• Inability to cooperate
• Inability to speak and understand Danish
• Allergy to local anaesthetics or opioids
• Daily intake of opioids (evaluated by the investigators)
• Drug and/or substance abuse
• Local infection at the site of injection or systemic infection
• Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
• Pregnant\* or breastfeeding
• Daily use of oral or intravenous steroids
• Known immune deficiency (evaluated by the investigators)
• Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer) within the last five years (within the last five years added 28th nov 2019 after ethics committee approval).

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, Department of Anaesthesiology

Roskilde, 4000, Denmark

Location

Related Publications (36)

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  BACKGROUND

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MeSH Terms

Conditions

Pain, Postoperative; Colonic Neoplasms

Interventions

Ropivacaine; Acetaminophen; Analgesia, Patient-Controlled; Morphine; Sodium Chloride; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Analgesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Katrine Tanggaard, MD

  Department of Anaesthesiology, Zealand University Hospital, Roskilde

  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: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 27, 2018
• Study Start: June 28, 2018
• Primary Completion: December 5, 2020
• Study Completion: January 3, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)