Spinal Morphine Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland

Analgesia Clinical Trial

Official title:

Spinal Morphine (0.05 mg) Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland- a Randomized Double-blinded Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458742
• Other study ID #: 019/2558(EC2)
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain after transurethral resection of prostate is considered mild to moderate severity from detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have been studied including spinal opioids, spinal anesthesia with local anesthetic and dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with distilled water irrigation while undergoing a procedure. Most of patients having this procedure are in elderly period, thus many anesthetists avoided spinal morphine which may cause respiratory depressant effect postoperatively. Although previous studies showed effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid side effects.

The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to spinal anesthesia with sole local anesthetic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > or = 18 years old

• Undergoing transurethral resection of prostate gland

Exclusion Criteria:

• Contraindication for spinal anesthesia for any reasons eg. infection, bleeding disorder

• Refuse spinal anesthesia

• Allergic to study drugs

• History of cerebrovascular disease or stroke

Related Conditions & MeSH terms

• Analgesia
• Spinal Anesthesia
• Transurethral Resection of Prostate

Intervention

Drug:
• Morphine
0.5%Hyperbaric bupivacaine 2 ml add morphine 50 mcg for spinal anesthesia
• Placebo
0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

References & Publications (8)

Duman A, Apiliogullari S, Balasar M, Gürbüz R, Karcioglu M. Comparison of 50 microg and 25 microg doses of intrathecal morphine on postoperative analgesic requirements in patients undergoing transurethral resection of the prostate with intrathecal anesthesia. J Clin Anesth. 2010 Aug;22(5):329-33. doi: 10.1016/j.jclinane.2009.09.006. — View Citation

Gorur S, Inanoglu K, Akkurt BC, Candan Y, Kiper AN. Periprostatic nerve blockage reduces postoperative analgesic consumption and pain scores of patients undergoing transurethral prostate resection. Urol Int. 2007;79(4):297-301. — View Citation

Kim JE, Kim NY, Lee HS, Kil HK. Effects of intrathecal dexmedetomidine on low-dose bupivacaine spinal anesthesia in elderly patients undergoing transurethral prostatectomy. Biol Pharm Bull. 2013;36(6):959-65. — View Citation

Kirson LE, Goldman JM, Slover RB. Low-dose intrathecal morphine for postoperative pain control in patients undergoing transurethral resection of the prostate. Anesthesiology. 1989 Aug;71(2):192-5. — View Citation

Köse O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan Ö. Prilocaine irrigation for pain relief after transurethral resection of the prostate. J Endourol. 2013 Jul;27(7):892-5. doi: 10.1089/end.2013.0001. Epub 2013 Jun 12. — View Citation

Ozbek H, Deniz MN, Erakgun A, Erhan E. Comparison of 75 and 150 µg doses of intrathecal morphine for postoperative analgesia after transurethral resection of the prostate under spinal anesthesia. J Opioid Manag. 2013 Nov-Dec;9(6):415-20. doi: 10.5055/jom.2013.0184. — View Citation

Sakai T, Use T, Shimamoto H, Fukano T, Sumikawa K. Mini-dose (0.05 mg) intrathecal morphine provides effective analgesia after transurethral resection of the prostate. Can J Anaesth. 2003 Dec;50(10):1027-30. — View Citation

Suksompong S, Pongpayuha P, Lertpaitoonpan W, von Bormann B, Phanchaipetch T, Sanansilp V. Low-dose spinal morphine for post-thoracotomy pain: a prospective randomized study. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):417-22. doi: 10.1053/j.jvca.2012.12.003. Epub 2013 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale (0-10)	Pain score rating by numerical rating scale in 24-hr postoperative	24 hours postoperatively
Secondary	Requirement of rescue pain	requirement of pain control medication	24 hours postoperatively
Secondary	Adverse effects	incidence of side effects e.g. nausea and vomiting, itching and sedation	24 hours postoperatively
Secondary	Satisfaction score	Satisfaction score rated from 0-100	24 hours postoperatively