Efficacy of Paravertebral Nerve Blockade to Reduce Pain Following Thoracoscopy

NCT01715701 | Completed

• 1 other identifier: SG2012-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess:

• The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to intercostal nerve blockade performed at the end of surgery on the intensity of postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.
• The incidence of chronic pain at 6 months following video-assisted thoracic surgery.
• The impact of preoperative multilevel paravertebral nerve blockade on patients' quality of life at 6 months following surgery compared to intercostal nerve blockade and to a control group using PCA alone. Hypothesis:
• The basic hypothesis of this study is that preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will provide superior postoperative analgesia and lower opioid consumption compared to PCA alone during the first 24 hours following surgery.
• Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence of chronic pain at 6 months following surgery.
• Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will shorten the length of stay in the intermediate intensive care unit and shorten the hospital stay.
• Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will reduce postoperative pulmonary complications.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Intensity of postoperative pain

  Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.

  From arrival in the recovery room until 48 hours following surgery

Secondary Outcomes (6)

• Opioid consumption

  From surgery until 48 hours following surgery

• Patient's satisfaction with pain relief

  From surgery until 48 hours following surgery

• Incidence of chronic pain

  Six months after surgery

• Length of stay in the recovery room

  From arrival to discharge from the recovery room (an expected average of one hour)

• Length of stay in the intermediate intensive care unit

  From arrival to discharge from the intermediate intensive care unit (an expected average of one day)

Study Arms (3)

Paravertebral nerve blockade

EXPERIMENTAL

A multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.

Procedure: Paravertebral nerve blockade

Intercostal nerve blockade

ACTIVE COMPARATOR

Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room.

Procedure: Intercostal nerve blockade

Patient Controlled Analgesia (PCA)

ACTIVE COMPARATOR

Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.

Procedure: Patient Controlled Analgesia

Interventions

Paravertebral nerve blockade PROCEDURE

Paravertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.

Paravertebral nerve blockade

Intercostal nerve blockade PROCEDURE

Intercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine.

Intercostal nerve blockade

Patient Controlled Analgesia PROCEDURE

Simulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.

Patient Controlled Analgesia (PCA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for an elective or emergency thoracoscopic surgery
• Physical status 1-4

You may not qualify if:

• Contraindication to paravertebral nerve blockade (coagulopathy, sepsis or local infection at the site of injection, spinal deformity)
• Severe renal or hepatic insufficiency
• A known allergy to local anesthetics, morphine or hydromorphone
• The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction
• Preexisting pain at the site of the surgical incision
• Current use of opioids, anticonvulsants or tricyclic antidepressants
• A recent history of drug or opioid abuse
• Patient refusal

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Sébastien Garneau, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

CA (1)