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  3. Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial
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Research Christmas 2020: Dr Strange

Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4284 (Published 10 December 2020) Cite this as: BMJ 2020;371:m4284

Linked Editorial

Can we sooth the subconscious during general anaesthesia?

Linked BMJ Opinion

Soothing words and music during surgery might reduce postoperative pain
  1. Hartmuth Nowak, senior physician1*,
  2. Nina Zech, senior physician2*,
  3. Sven Asmussen, senior physician1,
  4. Tim Rahmel, senior physician1,
  5. Michael Tryba, professor34,
  6. Guenther Oprea, senior physician1,
  7. Lisa Grause, doctoral student1,
  8. Karin Schork, statistician5,
  9. Manuela Moeller, doctoral student4,
  10. Johannes Loeser, senior physician6,
  11. Katharina Gyarmati, doctoral student6,
  12. Corinna Mittler, doctoral student6,
  13. Thomas Saller, senior physician7,
  14. Alexandra Zagler, doctoral student7,
  15. Katrin Lutz, doctoral student2,
  16. Michael Adamzik, professor1,
  17. Ernil Hansen, professor8
  1. 1Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Germany
  2. 2Department of Anesthesiology, University Hospital Regensburg, University of Regensburg, Regensburg, Germany
  3. 3Clinic for Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Kassel Hospital, Kassel, Germany
  4. 4Kassel School of Medicine, Kassel, Germany
  5. 5Medizinisches Proteom-Center, Ruhr University Bochum, Bochum, Germany
  6. 6Department of Anesthesiology and Intensive Care Medicine, University Hospital, University of Cologne, Cologne, Germany
  7. 7Department of Anaesthesiology, University Hospital, LMU Munich, Munich, Germany
  8. 8Department of Anaesthesiology, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93042 Regensburg, Germany
  9. *Contributed equally
  1. Correspondence to: E Hansen ernil.hansen{at}ukr.de
  • Accepted 6 November 2020

Abstract

Objective To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use.

Design Blinded randomised controlled study.

Setting Five tertiary care hospitals in Germany.

Participants 385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group.

Intervention The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape.

Main outcome measures The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain).

Results Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen’s d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported.

Conclusions Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery.

Trial registration German Clinical Trial Register DRKS00013800.

Footnotes

  • Contributors: HN and NZ contributed equally to the study. EH, NZ, and GO conceived and designed the study. EH and NZ developed and taped the intervention text. HN and NZ had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. AM and GO gave administrative support, including ethics committee approval and study registration. LG, MM, KG, CM, AZ, and KL acquired, analysed, and interpreted the data. NZ, SA, GO, MT, JH, and TS supervised the study in the five study centres. HN, NZ, TR, and KS did the statistical analysis and produced tables and figures. EH, NZ, and HN drafted the manuscript. All authors critically revised the manuscript for scientific content and approved the final version of the article. EH, HN, and NZ are the guarantors of the study. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: This study received no direct funding. Statistical analysis was partly supported by de.NBI, a project of the German Federal Ministry of Education and Research (BMBF) (grant No FKZ 031 A 534A), without any role in study design, data collection, and publication.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by the ethics committee of the Medical Faculty of the Ruhr-University Bochum (registration No 17-5957-BR). All ethics committees of the participating centres approved the study. All patients gave written informed consent.

  • Data sharing: The raw trial data after deidentification can be shared on individual request to the first author at hartmuth.nowak@kk-bochum.de. To gain access, data access agreement needs to be signed. Proposals will be considered up to 36 months after article publication.

  • The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.

  • Dissemination to participants and related patient and public communities: The results of the research will be disseminated to the public through press release, broadcasts, popular science articles, and newspapers.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

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