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

NCT ID: NCT02458742

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Anesthesia Transurethral Resection of Prostate Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Morphine

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

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

Placebo

0.5%Bupivacaine 2 ml for spinal anesthesia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia

Interventions

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Morphine

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

Intervention Type DRUG

Placebo

0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia

Intervention Type DRUG

Other Intervention Names

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Hyperbaric bupivacaine with morphine Hyperbaric bupivacaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pawinee Pangthipampai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

References

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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.

Reference Type BACKGROUND
PMID: 23565930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18025845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23727917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23545346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20650378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2667399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24481930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14656781 (View on PubMed)

Other Identifiers

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019/2558(EC2)

Identifier Type: -

Identifier Source: org_study_id

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