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

Sponsor

Mahidol University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03280017

Collaborator

(none)

Enrollment

Location

Arms

27.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Pain, Chronic Pain, Neuropathic	Drug: Ketamine Drug: Normal saline	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study

Actual Study Start Date :

Sep 25, 2017

Anticipated Primary Completion Date :

Sep 30, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Ketamine intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
Placebo Comparator: 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	Drug: Normal saline normal saline infusion

Arm

Intervention/Treatment

Experimental: 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

Drug: Ketamine

intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)

Placebo Comparator: 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

Drug: Normal saline

normal saline infusion

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 [1 month]
The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
Chronic post-surgical pain [3 months]
The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively