Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain

Phase 4

Completed

• Conditions: Pain, Chronic; Pain, Neuropathic; Pain, Acute
• Interventions: Drug: Normal saline; Drug: Ketamine

• Registration Number: NCT03280017
• Lead Sponsor: Mahidol University

Brief Summary

Postoperative pain after thoracic surgery is associated with adverse outcomes. The current strategy to prevent postoperative pain is the use of regional anesthesia and analgesic agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become the standard analgesic regimen which results in decreased postoperative pain and opioid consumption.

The investigator would like to study the analgesic efficacy of low dose intravenous ketamine infusion during surgery in combination with thoracic paravertebral block on postoperative pain after VATS in a randomized study.

Detailed Description

Inadequate pain control after thoracic surgery is associated with adverse events such as postoperative pulmonary complications (PPC), and chronic post surgical pain.

Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively as it produces optimal surgical outcomes and possible less postoperative pain, there are reports of inadequate pain control.

Thoracic paravertebral block (TPVB) has been introduced as an effective method in postoperative pain management after VATS. It is associated with improved pain control and the reduction of opioid analgesic consumption in several studies.

The use of intravenous low dose ketamine infusion during and after surgery has been shown to produce superior postoperative pain control in upper abdominal surgery and thoracotomy.

The aim of the present study is to study the efficacy of intravenous low dose ketamine infusion during surgery on acute and chronic pain after VATS.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-10
• Study First Submitted QC: 2017-09-10
• Study First Posted: 2017-09-12
• Study Start: 2017-09-25
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-11
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• American Society of Anesthesiologist physical status 1-3
• Scheduled for elective video-assisted thoracic surgery
• Able to operate a patient-controlled analgesia device (PCA)

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Exclusion Criteria

• History of morphine allergy
• History of bupivacaine allergy
• Contraindication for ketamine infusion
• Contraindication for thoracic paravertebral block
• Anticipated postoperative positive pressure ventilation
• Body mass index more than 35
• Any known psychiatric disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Participant allocated to this arm will receive intravenous normal saline solution infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
Ketamine	Ketamine	Participant allocated to this arm will receive intravenous ketamine infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	24 hours postoperatively	Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)

Secondary Outcome Measures

Name	Time	Method
Time to first analgesia	24 hours postoperatively	Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device
Peak flow rates (day 1)	1 days	The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
Peak flow rates (day 2)	2 days	The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
Chronic post-surgical pain	3 months	The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand