Trial Outcomes & Findings for Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine (NCT NCT01087931)

NCT ID: NCT01087931

Last Updated: 2018-06-25

Results Overview

Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: about 4 to 5 weeks after surgery
• Results posted on: 2018-06-25

Participant Flow

Participant milestones

Measure	Bupivacaine This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.	Saline This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.
Overall Study STARTED	20	20
Overall Study 1st Follow up	20	19
Overall Study Final Follow up	19	17
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine

Baseline characteristics by cohort

Measure	Bupivacaine n=20 Participants This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.	Saline n=20 Participants This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.	Total n=40 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 12 • n=93 Participants	62 years STANDARD_DEVIATION 8 • n=4 Participants	64 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: about 4 to 5 weeks after surgery

Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.

Outcome measures

Measure	Saline n=19 Participants This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.	Bupivacaine n=20 Participants This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.
Pain, Cumulative Visual Analog Score, 1st Follow Up	21.7 units on a scale Standard Deviation 17	10.5 units on a scale Standard Deviation 11

PRIMARY outcome

Timeframe: about 18 to 20 weeks after surgery

Population: Original study data has been lost. Estimated values obtained from a figure describing the results in the study results publication are reported in the data table.

Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.

Outcome measures

Measure	Saline n=19 Participants This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.	Bupivacaine n=20 Participants This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.
Pain, Cumulative Visual Analog Score, Final Follow up	29.33 units on a scale Standard Deviation 7.11	15.33 units on a scale Standard Deviation 5.55

SECONDARY outcome

Timeframe: about 4 to 5 weeks after surgery

Number of participants using narcotics for pain

Outcome measures

Measure	Saline n=19 Participants This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.	Bupivacaine n=20 Participants This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.
Narcotic Use, 1st Follow up	13 Participants	9 Participants

SECONDARY outcome

Timeframe: about 18 to 20 weeks after surgery

Number of participants using narcotics for pain

Outcome measures

Measure	Saline n=17 Participants This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.	Bupivacaine n=19 Participants This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.
Narcotic Use, Final Follow up	3 Participants	1 Participants

Adverse Events

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bupivacaine n=20 participants at risk This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. Bupivacaine: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.	Saline n=20 participants at risk This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site. Normal Saline: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.
Infections and infestations Superficial Infection	0.00% 0/20 • 20 weeks Original study data is lost. Adverse event data was pulled from publication based on study.	5.0% 1/20 • Number of events 1 • 20 weeks Original study data is lost. Adverse event data was pulled from publication based on study.

Additional Information

Kevin O'Neill

Vanderbilt University

Phone: 615-936-5677

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place