Clinical trial NCT02458742: Spinal Morphine Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Transurethral Resection of Prostate
Analgesia
Keywords: spinal anesthesia
intrathecal morphine
transurethral resection of prostate
postoperative pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numerical rating scale (0-10)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Requirement of rescue pain
timeFrame: 24 hours postoperatively
measure: Adverse effects
timeFrame: 24 hours postoperatively
measure: Satisfaction score
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Siriraj Hospital
name: Pawinee Pangthipampai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kose O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan O. 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.
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. doi: 10.1159/000109712.
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. doi: 10.1248/bpb.b12-01067.
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.
citation: Duman A, Apiliogullari S, Balasar M, Gurbuz 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.
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. doi: 10.1097/00000542-198908000-00004.
citation: Ozbek H, Deniz MN, Erakgun A, Erhan E. Comparison of 75 and 150 mug 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.
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. doi: 10.1007/BF03018367.