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

NCT02458742 | Completed DMC

• 1 other identifier: 019/2558(EC2)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Anesthesia; Transurethral Resection of Prostate; Analgesia

Keywords

spinal anesthesia; intrathecal morphine; transurethral resection of prostate; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (0-10)

  Pain score rating by numerical rating scale in 24-hr postoperative

  24 hours postoperatively

Secondary Outcomes (3)

• Requirement of rescue pain

  24 hours postoperatively

• Adverse effects

  24 hours postoperatively

• Satisfaction score

  24 hours postoperatively

Study Arms (2)

Morphine

EXPERIMENTAL

0.5%Bupivacaine 2 ml with morphine 50 mcg for spinal anesthesia

Drug: Morphine

Placebo

PLACEBO COMPARATOR

0.5%Bupivacaine 2 ml for spinal anesthesia

Drug: Placebo

Interventions

Morphine DRUG

0.5%Hyperbaric bupivacaine 2 ml add morphine 50 mcg for spinal anesthesia

Also known as: Hyperbaric bupivacaine with morphine

Morphine

Placebo DRUG

0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia

Also known as: Hyperbaric bupivacaine

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years old
• Undergoing transurethral resection of prostate gland

You may not qualify if:

• Contraindication for spinal anesthesia for any reasons eg. infection, bleeding disorder
• Refuse spinal anesthesia
• Allergic to study drugs
• History of cerebrovascular disease or stroke

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (8)

• 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.

  PMID: 23565930 BACKGROUND

• 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.

  PMID: 18025845 BACKGROUND

• 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.

  PMID: 23727917 BACKGROUND

• 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.

  PMID: 23545346 BACKGROUND

• 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.

  PMID: 20650378 BACKGROUND

• 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.

  PMID: 2667399 BACKGROUND

• 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.

  PMID: 24481930 BACKGROUND

• 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.

  PMID: 14656781 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pawinee Pangthipampai, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 15, 2019

Record last verified: 2019-01