Title

Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.
  • Phase

    N/A
  • Study Type

    Interventional
  • Study Participants

    96
Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.
This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.

Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.
Study Started
Dec 31
2008
Primary Completion
Nov 30
2009
Study Completion
Feb 28
2010
Results Posted
Nov 07
2014
Estimate
Last Update
Nov 07
2014
Estimate

Drug 0.5% bupivacaine

Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour.

  • Other names: Marcaine

Drug Normal Saline

The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.

  • Other names: Saline

Control group No Intervention

The control group patients will receive no continuous infusion catheter.

Placebo group Placebo Comparator

The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.

Study Group Experimental

Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.

Criteria

Inclusion Criteria:

Full thickness rotator cuff tear
Pre operative MRI
Patients who are medically stable to undergo the surgery
Patients who consent to involvement in the study

Exclusion Criteria:

Prior surgery on the involved shoulder
Preoperative MRI suggesting that the rotator cuff tear is unrepairable
Patients with known allergies to oxycodone, bupivacaine or a similar drug
Workman's compensation patients
Patients who do not fill out their visual analog scores or their medication diaries.

Summary

Placebo Group

Control Group

Study Group

All Events

Event Type Organ System Event Term

Pain Scores

Pain was measured via Visual Analong Scale in measurement (0-100mm).

Placebo Group

Pain at 12 hours

46.6
mm (Mean)
Standard Deviation: 28.0

Pain at 1 hour

60.0
mm (Mean)
Standard Deviation: 19.5

Pain at 2 hours

60.5
mm (Mean)
Standard Deviation: 23.2

Pain at 3 hours

60.0
mm (Mean)
Standard Deviation: 24.5

Pain at 4 hours

52.6
mm (Mean)
Standard Deviation: 26.5

Pain at 5 hours

54.5
mm (Mean)
Standard Deviation: 25.5

Pain at 6 hours

42.9
mm (Mean)
Standard Deviation: 26.6

Pain at 72 hours

45.0
mm (Mean)
Standard Deviation: 18.7

Pain at baseline

64.7
mm (Mean)
Standard Deviation: 25.9

Control Group

Pain at 12 hours

35.8
mm (Mean)
Standard Deviation: 22.7

Pain at 1 hour

59.7
mm (Mean)
Standard Deviation: 26.5

Pain at 2 hours

62.0
mm (Mean)
Standard Deviation: 26.0

Pain at 3 hours

55.3
mm (Mean)
Standard Deviation: 27.1

Pain at 4 hours

50.3
mm (Mean)
Standard Deviation: 28.7

Pain at 5 hours

48.6
mm (Mean)
Standard Deviation: 24.1

Pain at 6 hours

37.3
mm (Mean)
Standard Deviation: 22.3

Pain at 72 hours

41.1
mm (Mean)
Standard Deviation: 18.1

Pain at baseline

43.9
mm (Mean)
Standard Deviation: 33.6

Study Group

Pain at 12 hours

42.8
mm (Mean)
Standard Deviation: 29.0

Pain at 1 hour

52.3
mm (Mean)
Standard Deviation: 25.8

Pain at 2 hours

50.7
mm (Mean)
Standard Deviation: 24.2

Pain at 3 hours

51.2
mm (Mean)
Standard Deviation: 27.6

Pain at 4 hours

46.8
mm (Mean)
Standard Deviation: 27.3

Pain at 5 hours

46.7
mm (Mean)
Standard Deviation: 33.2

Pain at 6 hours

42.2
mm (Mean)
Standard Deviation: 32.0

Pain at 72 hours

42.7
mm (Mean)
Standard Deviation: 19.2

Pain at baseline

51.4
mm (Mean)
Standard Deviation: 31.1

Total

88
Participants

Age, Continuous

57
years (Mean)
Standard Deviation: 0.8

Region of Enrollment

Sex: Female, Male

Overall Study

Placebo Group

Control Group

Study Group