Pain, Postoperative Clinical Trial
— Annie-DimitrOfficial title:
Morphine Versus Ketamine as Adjuvants in Ultrasound-guided Paravertebral Thoracic Blocks in Elective Thoracic Surgery
Verified date | May 2023 |
Source | Aretaieion University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study will be to compare the effects of morphine versus ketamine when they are used as adjuvants to the local anesthetic in paravertebral nerve blocks performed with the aid of ultrasound. Furthermore, a group of local anesthetic without an adjuvant, will also be compared to the two groups
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | April 16, 2024 |
Est. primary completion date | April 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | Inclusion Criteria: - patients undergoing elective thoracotomy for any cause - American Society of Anesthesiologists class I-III (ASA I-III) Exclusion Criteria: - known allergy to local anesthetic - local inflammation - paravertebral tumor - severe respiratory distress ( breathing dependence on accessory muscles) - severe spinal deformities - severe ipsilateral diaphragmatic paresis - morbid obesity (BMI>35 kg/m2) - blood coagulation disorders - known contraindication for administration of ketamine or morphine - psychiatric disorders - severe cardiovascular disease - systematic use of opioids due to chronic pain - renal or hepatic failure - patients who refuse to participate |
Country | Name | City | State |
---|---|---|---|
Greece | Aretaieion University Hospital | Athens | |
Greece | KAT General Hospital of Athens | Athens |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital | KAT General Hospital |
Greece,
Ahmed MJ, Ur Rehman A, Arshad RM, Amjad MWA, Khan Z, Furqan A. Efficacy of Dexmedetomidine vs Morphine as an Adjunct in a Paravertebral Block with Bupivacaine in Postoperative Analgesia Following Modified Radical Mastectomy. Cureus. 2020 May 22;12(5):e8231. doi: 10.7759/cureus.8231. — View Citation
D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4. — View Citation
El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17. — View Citation
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. — View Citation
Kathirvel S, Sadhasivam S, Saxena A, Kannan TR, Ganjoo P. Effects of intrathecal ketamine added to bupivacaine for spinal anaesthesia. Anaesthesia. 2000 Sep;55(9):899-904. doi: 10.1046/j.1365-2044.2000.01472.x. — View Citation
Mao Y, Zuo Y, Mei B, Chen L, Liu X, Zhang Z, Gu E. Efficacy of perineural dexamethasone with ropivacaine in thoracic paravertebral block for postoperative analgesia in elective thoracotomy: a randomized, double-blind, placebo-controlled trial. J Pain Res. 2018 Sep 11;11:1811-1819. doi: 10.2147/JPR.S164225. eCollection 2018. — View Citation
Maruyama Y, Shimoji K, Shimizu H, Sato Y, Kuribayashi H, Kaieda R. Effects of morphine of human spinal cord and peripheral nervous activities. Pain. 1980 Feb;8(1):63-73. doi: 10.1016/0304-3959(80)90090-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | morphine consumption in the first 48 hours | patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively | 48 hours postoperatively | |
Secondary | morphine consumption in Post-Anesthesia Care Unit (PACU) | mg of morphine requested during patient PACU stay | 24 hours postoperatively | |
Secondary | pain score on arrival to Post-Anesthesia Care Unit (PACU) | pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | immediately postoperatively | |
Secondary | pain score 6 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | 6 hours postoperatively | |
Secondary | pain score 12 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | 12 hours postoperatively | |
Secondary | pain score 24 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | 24 hours postoperatively | |
Secondary | pain score 48 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 48 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | 48 hours postoperatively | |
Secondary | morphine consumption in the first 6 hours | patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 6 hours postoperatively | 6 hours postoperatively | |
Secondary | morphine consumption in the first 12 hours | patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 12 hours postoperatively | 12 hours postoperatively | |
Secondary | morphine consumption in the first 24 hours | patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 24 hours postoperatively | 24 hours postoperatively | |
Secondary | side effects postoperatively | patients will be monitored for side-effects of the administered agents postoperatively | 96 hours postoperatively | |
Secondary | satisfaction from postoperative analgesia | satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction | 48 hours postoperatively | |
Secondary | morphine requirement during surgery | dose of required morphine administered intraoperatively | intraoperatively | |
Secondary | time to first request for analgesia | the time for the first patient request for analgesia will be noted | during stay in Post-Anesthesia Care Unit, 24 hours postoperatively | |
Secondary | hospitalization time | duration of hospital stay after surgery in days | 7 days postoperatively | |
Secondary | incidence of chronic pain 3 months after surgery | occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement | 3 months after surgery | |
Secondary | incidence of chronic pain 6 months after surgery | occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement | 6 months after surgery |
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