Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

Postoperative Pain Clinical Trial

Official title:

Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313675
• Other study ID #: PRO14110464
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: April 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

Description:

The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• carpal tunnel release surgery candidates,

• distal radius fracture surgery candidates

Exclusion Criteria:

• under 18 years of age,

• pregnant women,

• prisoners

Related Conditions & MeSH terms

• Carpal Tunnel Release
• Carpal Tunnel Syndrome
• Distal Radius Fracture
• Fractures, Bone
• Pain, Postoperative
• Postoperative Pain
• Radius Fractures

Intervention

Drug:
• Acetaminophen

• Ketorolac Tromethamine

• Saline

Locations

Country	Name	City	State
United States	Kaufmann Building	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
John Fowler

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. Epub 2006 Apr 13. — View Citation

Baley K, Michalov K, Kossick MA, McDowell M. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. AANA J. 2014 Feb;82(1):53-64. Review. — View Citation

Hahn TW, Mogensen T, Lund C, Jacobsen LS, Hjortsoe NC, Rasmussen SN, Rasmussen M. Analgesic effect of i.v. paracetamol: possible ceiling effect of paracetamol in postoperative pain. Acta Anaesthesiol Scand. 2003 Feb;47(2):138-45. — View Citation

Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain (Pain Scores From 0-10 Scale)	This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.	7 days
Secondary	Opioid Consumption (Number of Pills Taken)	Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively; Outcome measure reported below is mean number of opioid pills consumed per day.	7 days