Transdermal buprenorphine for postoperative pain control in gynecological surgery: a prospective randomized study

Abstract

Objective:

Although numerous methods are available for postoperative pain (POP) management, new approaches are constantly being investigated. This feasibility study assessed the buprenorphine transdermal therapeutic system (Bup-TTS) for the treatment of POP after gynecological open surgery.

Research design and methods:

Forty-five patients were prospectively randomized to different Bup-TTS dosages (17.5, 35, or 52.5 μg/h). Patients were blinded with regard to patch dose.

Main outcome measures:

Efficacy was evaluated in terms of rescue boluses (intravenous morphine 2 mg in the first six postoperative hours, intravenous ketorolac 30 mg thereafter) required to achieve a static and dynamic Numerical Rating Scale (sNRS and dNRS) score ≤4. Side effects were evaluated from patch application (12 hours before surgery) until the 72nd postoperative hour. Patient satisfaction regarding POP management was assessed via anonymous questionnaire.

Results:

All Bup-TTS groups required additional postoperative analgesia, particularly in the first postoperative hour. No between-group differences in sNRS/dNRS values were recorded at emergence from anesthesia. A significant inverse correlation occurred between Bup-TTS dosage and use of morphine (p = 0.04), ketorolac (p = 0.04) or both rescues (p = 0.02). Postoperative nausea/vomiting occurred in 3.1% of assessments, with no between-group differences and a significant correlation with morphine amount (p = 0.01). No serious side effects occurred. Despite no between-group difference, patient satisfaction was inversely correlated with the number of rescue doses (p < 0.001). Study limitations include the small sample size, the absence of a control group treated with a more conventional technique for POP relief, the focus on selected patients at low perioperative risk and the presence of slightly different types of open surgery (hysterectomy vs myomectomy only).

Conclusion:

Bup-TTS efficacy was directly proportional to its dosage, although additional analgesia was required, particularly in the first postoperative hour. Moreover, the consumption of morphine and ketorolac was inversely correlated to the Bup-TTS dosage. Increasing Bup-TTS doses were not associated with an increased incidence of side effects. Bup-TTS appears a safe and feasible approach for moderate POP management; further larger studies are warranted.

Keywords::

• Analgesia
• Gynecological surgery
• Postoperative pain
• Transdermal buprenorphine

Transparency

Declaration of funding

This study was funded by Grünenthal GmbH, Aachen, Germany.

Declaration of financial/other relationships

T.S., F.S., and Y.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. All three authors contributed equally to this clinical research.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

We are grateful to the nursing staff of the theatres, Recovery Room and Gynecological Ward of the ‘Santa Maria degli Angeli’ Hospital – Pordenone, Italy, for their support during this study and for the careful collection of the data. We are also very thankful to Doctor Duilio Ferrari who performed the statistical analysis of our data and to David P. Figgitt PhD, Content Ed Net, for providing editorial assistance in the preparation of this manuscript; editorial assistance and statistical analyses were funded by Grünenthal GmbH, Aachen, Germany.

Notes

*Transtec is a registered trade name of Grunenthal, Aachen, Germany.