Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration

NCT03035942 | Completed Phase 4 Results DMC

• 1 other identifier: PUCSP 1863886
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate not only the occurrence of side effects, but the quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg), dexamethasone (8mg) or placebo.

Conditions

Fractures, Bone; Nausea and Vomiting, Postoperative; Pruritus; Morphine Adverse Reaction; Satisfaction, Personal

Keywords

Intrathecal morphine; Nausea and vomiting; Quality of recovery; Patient satisfaction; Pruritus; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome

  Twenty four hours after surgery by a blinded investigator

Secondary Outcomes (3)

• Nausea and Vomiting During PACU Staying

  4h

• Number of Participants With Pruritus

  24 hours

• Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)

  24 hours

Study Arms (3)

D Group

EXPERIMENTAL

Dexamethasone 8 mg

Drug: Dexamethasone

O group

EXPERIMENTAL

Ondansetron 4 mg

Drug: Ondansetron

S group

PLACEBO COMPARATOR

Normal saline (5 mL total volume)

Drug: Saline

Interventions

Dexamethasone DRUG

Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.

Also known as: D Group

D Group

Ondansetron DRUG

Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.

Also known as: O Group

O group

Saline DRUG

Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.

Also known as: Placebo Group

S group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures

You may not qualify if:

• Patients who:
• (i) refused to participate in the study;
• (ii) were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;
• (iii) presented with contraindication to any of the drugs used in the present study;
• (iv) had history of alcohol or drug abuse and
• (v) had surgery in the last 10 days were excluded.

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Santa Lucinda Hospital

Sorocaba, São Paulo, 18030-230, Brazil

Location

Related Publications (9)

• Jacobson L, Chabal C, Brody MC, Ward RJ, Wasse L. Intrathecal methadone: a dose-response study and comparison with intrathecal morphine 0.5 mg. Pain. 1990 Nov;43(2):141-148. doi: 10.1016/0304-3959(90)91066-R.

  PMID: 2087326 BACKGROUND

• Slappendel R, Weber EW, Dirksen R, Gielen MJ, van Limbeek J. Optimization of the dose of intrathecal morphine in total hip surgery: a dose-finding study. Anesth Analg. 1999 Apr;88(4):822-6. doi: 10.1097/00000539-199904000-00026.

  PMID: 10195531 BACKGROUND

• Koju RB, Gurung BS, Dongol Y. Prophylactic administration of ondansetron in prevention of intrathecal morphine-induced pruritus and post-operative nausea and vomiting in patients undergoing caesarean section. BMC Anesthesiol. 2015 Feb 17;15:18. doi: 10.1186/1471-2253-15-18.

  PMID: 25971957 BACKGROUND

• Braga AA, Frias JA, Braga FS, Poterio GB, Hirata ES, Torres NA. Spinal anesthesia for cesarean section. Use of hyperbaric bupivacaine (10mg) combined with different adjuvants. Rev Bras Anestesiol. 2012 Nov-Dec;62(6):775-87. doi: 10.1016/S0034-7094(12)70178-2.

  PMID: 23176986 BACKGROUND

• Krajnik M, Zylicz Z. Understanding pruritus in systemic disease. J Pain Symptom Manage. 2001 Feb;21(2):151-68. doi: 10.1016/s0885-3924(00)00256-6.

  PMID: 11226766 BACKGROUND

• Griffiths JD, Gyte GM, Paranjothy S, Brown HC, Broughton HK, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007579. doi: 10.1002/14651858.CD007579.pub2.

  PMID: 22972112 BACKGROUND

• Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.

  PMID: 17275282 BACKGROUND

• Szarvas S, Chellapuri RS, Harmon DC, Owens J, Murphy D, Shorten GD. A comparison of dexamethasone, ondansetron, and dexamethasone plus ondansetron as prophylactic antiemetic and antipruritic therapy in patients receiving intrathecal morphine for major orthopedic surgery. Anesth Analg. 2003 Jul;97(1):259-63, table of contents. doi: 10.1213/01.ane.0000066310.49139.2a.

  PMID: 12818978 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Postoperative Nausea and Vomiting; Pruritus; Personal Satisfaction; Nausea; Vomiting; Patient Satisfaction; Pain, Postoperative

Interventions

Dexamethasone; Ondansetron; O-antigen, Acinetobacter strain 90; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Behavior; Treatment Adherence and Compliance; Health Behavior; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Eduardo Toshiyuki Moro
• Organization: Pontificia Catholic University of Sao Paulo

edumoro85@gmail.com

+5515997728015

Study Officials

• Eduardo T Moro, Professor

  PUC São Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignments will be sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients will be blinded to group assignments. Study 5-mL syringes will be prepared by a nurse independent of the study. Normal saline (5 mL total volume), dexamethasone (made up to 5 mL with normal saline), or ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD, PhD

Model Details: Prospective, randomized, controlled, double-blinded

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: January 2, 2017
• Primary Completion: October 1, 2018
• Study Completion: November 4, 2019
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)