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Clinical trials: what should we assess?

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Regional Analgesia in Obstetrics
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Abstract

The culture of evidence-based medicine dictates that clinical decisions are made in the light of the best available evidence. In ascending order of validity, that evidence maybe found in the form of case reports, expert consensus opinions, laboratory experiments, randomised clinical trials (RCTs) or meta-analyses. In broad terms, case reports supply inadequate information on which to base decisions that may influence a large and varying population. Consensus opinions offer experience-based guidelines, but usually with the caveat that evidence is lacking on specifics. Laboratory experiments address those specifics, but suffer from the criticism of being remote from the clinical environment. The theory of design and method of the RCT, the building block of meta-analysis, are accessible to most. Thus, examples may be found for a wide spectrum of clinical situations, and so it is this level of evidence upon which many clinical decisions are based. Meta-analysis occupies the scientific high ground, but requires that comparable quality data are available from multiple RCTs, and controversy persists as to whether they amplify rather than reduce the problems experienced with RCTs.

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References

  1. Patel M, Craig R, Laishley R. A comparison between epidural anaesthesia using alkalinized solution and spinal (combined spinal/epidural) anaesthesia for elective caesarean section. International Journal of Obstetric Anesthesia 1996; 5: 236–9

    Article  PubMed  CAS  Google Scholar 

  2. Hapidou EG, De Cantazaro D. Responsiveness to laboratory pain in women as a function of age and childbirth pain experience. Pain 1992; 48: 177–81

    Article  PubMed  CAS  Google Scholar 

  3. Niven C, Gijsbers K. A study of labour pain using the McGill Pain Questionnaire. Soc Sci Med 1984; 19: 1347–51

    Article  PubMed  CAS  Google Scholar 

  4. Sheiner E, Sheiner EK, Shoham-Vardi I. The relationship between parity and labor pain. Inter J Gynaecol Obstet 1987; 63: 287–8

    Article  Google Scholar 

  5. Lowe NK. Parity and pain during parturition. J Obstet Gynecol Neonat Nurs 1987; 16: 340–346

    Article  CAS  Google Scholar 

  6. Bonnel AM, Boureau F. Labor pain assessment: validity of a behavioral index. Pain 1985; 22: 81–90

    Article  PubMed  CAS  Google Scholar 

  7. Andrews PJ, Ackerman WE, Junega MJ, Vogel R. Facial sensory evoked muscle potentials during labour. A continuous objective monitor of adequacy of analgesia? Anaesthesia 1995; 50: 9–13

    Article  PubMed  CAS  Google Scholar 

  8. Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 1994; 56: 217–26

    Article  PubMed  CAS  Google Scholar 

  9. Husemeyer RP, O’Connor MC, Davenport HT. Failure of epidural morphine to relieve pain in labour. Anaesthesia 1980; 35: 161–3

    Article  PubMed  CAS  Google Scholar 

  10. Banos JE, Bosch F, Canellas M, Bassols A, Ortega F, Bigorra J. Acceptability of visual analogue scales in the clinical setting: a comparison with verbal rating scales in postoperative pain. Methods Find Exp Clin Pharmacol 1989; 11: 123–7

    PubMed  CAS  Google Scholar 

  11. Liu WH, Aitkenhead AR. Comparison of contemporaneous and retrospective assessment of postoperative pain using visual analogue scale. Br J Anaesth 1991; 67: 768–71

    Article  PubMed  CAS  Google Scholar 

  12. Niven CA, Gijsbers K. Coping with labor pain. J Pain Symptom Manage 1996; 11: 116–25

    Article  PubMed  CAS  Google Scholar 

  13. Dexter F. Analysis of statistical tests to compare doses of analgesics among groups. Anesthesiology 1994; 81: 610–15

    Article  PubMed  CAS  Google Scholar 

  14. Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med 1998; 5: 1089–90

    Article  Google Scholar 

  15. Norvell KT, Gaston-Johansson F, Fridh G. Remembrance of labor pain: how valid are retrospective pain measurements? Pain 1987; 31: 77–86

    Article  PubMed  CAS  Google Scholar 

  16. Ludington E, Dexter F. Statistical analysis of total labor pain using the visual analog scale and application to studies of analgesic effectiveness during childbirth. Anesth Analg 1998; 87: 723–7

    PubMed  CAS  Google Scholar 

  17. Camann W. Visual analogue scale scores for labor pain. Anesth Analg 1999; 88: 1421

    PubMed  CAS  Google Scholar 

  18. Morgan BM, Bulpitt CJ, Clifton P, Lewis PJ. Analgesia and satisfaction in childbirth (the Queen Charlotte’s 1000 mother survey). Lancet 1982; ii: 808–10

    Article  Google Scholar 

  19. Ranta P, Spalding M, Kangas-Saarela T, Jokela R, Hollmen A, Jouppila, P, Jouppila, R. Maternal expectations and experiences of labour pain - opinions of 1091 Finnish parturients. Acta Anaesthesiol Scand 1995; 39: 60–6

    Article  PubMed  CAS  Google Scholar 

  20. Robinson N, Salmon P, Yentis S. Maternal satisfaction. International Journal of Obstetric Anesthesia 1998; 7: 32–7

    Article  PubMed  CAS  Google Scholar 

  21. Morgan P, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. International Journal of Obstetric Anesthesia 1999; 8: 165–70

    Article  PubMed  CAS  Google Scholar 

  22. Russell I. Testing regional anaesthesia before caesarean section. Anaesthesia 1998; 53: 93–4

    Article  PubMed  CAS  Google Scholar 

  23. Rocco A, Raymond S, Murray E, Dhingra U, Freiberger D. Differential spread of blockade of touch, cold and pinprick during spinal anesthesia. Anesth Analg 1985; 64: 917–23

    Article  PubMed  CAS  Google Scholar 

  24. Brull S, Greene N. Zones of differential sensory block during extradural anaesthesia. Br J Anaesth 1991; 66: 651–5

    Article  PubMed  CAS  Google Scholar 

  25. Bourne T, deMelo A, Bastinpillai B, Maye A. A survey of how British obstetric anaesthetists test regional anaesthesia before caesarean section. Anaesthesia 1997; 52: 901–3

    Article  PubMed  CAS  Google Scholar 

  26. Fruhstorfer H. A simple technique for estimating the level of analgesia in regional anesthesia. Reg Anesth 1991; 14: 106–7

    CAS  Google Scholar 

  27. Schwagmeier R, Braun C, Nolte H. Determination of the spread of epidural anesthesia. A comparison between pin-prick and a new method using a metallic roller. Anaesthetist 1992; 41: 58–60

    CAS  Google Scholar 

  28. Hughes J, Harmer M. A new gas jet method for the assessment of sensory block after spinal anaesthesia. Anaesthesia 1998; 53: 197–200

    Article  PubMed  CAS  Google Scholar 

  29. Jones M, Bogod D, Rees G, Rosen M. Midwive’s assessment of the upper sensory level after epidural blockade. Anaesthesia 1988; 43: 557–9

    Article  PubMed  CAS  Google Scholar 

  30. Zaric D, Hallgren S, Leissner L, et al. Evaluation of epidural sensory block by thermal stimulation, laser stimulation, and recording of somatosensory evoked potentials. Reg Anesth 1996; 21: 124–38

    PubMed  CAS  Google Scholar 

  31. Bourne T, Campbell F, Mushambi M, Maye A. Patients assessment of sensory levels during epidural analgesia in labour. International Journal of Obstetric Anesthesia 1997; 6: 239–41

    Article  PubMed  CAS  Google Scholar 

  32. Griffin, Reynolds F. The association between foot temperature and asymmetrical epidural blockade. International Journal of Obstetric Anesthesia 1994; 3: 132–6

    Article  PubMed  CAS  Google Scholar 

  33. Nydahl P, Axelsson K, Philipson L, Leissner P, Larsson P. Motor blockade and EMG recordings in epidural anaesthesia. A comparison between mepivacaine 2%, bupivacaine 0.5% and etidocaine 1.5%. Acta Anaesthesiol Scand 1989; 33: 597–604

    Article  PubMed  CAS  Google Scholar 

  34. Ilsley AH, Brownridge P, Plummer JL, Jones ME. A force meter to assess lower limb motor function after epidural analgesia. Reg Anesth 1993; 18: 339–42

    PubMed  CAS  Google Scholar 

  35. Buggy D, Hughes N, Gardiner J. Posterior column sensory impairment during ambulatory extradural analgesia in labour. Br J Anesth 1994; 73: 540–2

    Article  CAS  Google Scholar 

  36. Parry MG, Fernando R, Bawa GPS, Poulton BB. Dorsal column function after epidural and spinal blockade: implications for the safety of walking following low-dose regional analgesia for labour. Anaesthesia 1998; 53: 382–403

    Article  PubMed  CAS  Google Scholar 

  37. Pickering AE, Parry MG, Ousta B, Fernando R. Effect of combined spinal-epidural ambulatory analgesia on balance. Anesthesiology 1999; 91: 436–41

    Article  PubMed  CAS  Google Scholar 

  38. Norris M, Grieco W, Borkowski M, et al. Complications of labor analgesia: epidural versus combined spinal epidural techniques. Anesth Analg 1994; 79: 529–37

    Article  PubMed  CAS  Google Scholar 

  39. Kinsella S, Black A. Reporting of “hypotension” after epidural analgesia during labour. Effect of choice of arm and timing of baseline readings. Anaesthesia 1998; 53: 131–5

    Article  PubMed  CAS  Google Scholar 

  40. Schmulian C, Kenny G, Campbell D. Use of microcomputers for self-assessment and continuing education in anaesthesia. BMJ 1982; 284: 403–5

    Article  PubMed  CAS  Google Scholar 

  41. Kopacz D, Neal J, Pollock J. The regional anesthesia “learning curve”: what is the minimum number of epidural and spinal blocks to reach consistency? Reg Anesth 1996; 21: 189–90

    Google Scholar 

  42. Konrad C, Schupfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesth Analg 1998; 86: 635–9

    PubMed  CAS  Google Scholar 

  43. Kestin I. A statistical approach to measuring the competence of anaesthetic trainees at practical procedures. Br J Anaesth 1995; 75: 805–9

    Article  PubMed  CAS  Google Scholar 

  44. Yentis S, Robinson N. Definitions in obstetric anaesthesia: how should we measure anaesthetic workload and what is “epidural rate”? Anaesthesia 1999; 10: 958–62

    Article  Google Scholar 

  45. Cohen S, Subak L, Brose W, Halpern J. Analgesia after cesarean delivery: patient evaluations and costs of five opioid techniques. Reg Anesth 1991; 16: 141–9

    PubMed  CAS  Google Scholar 

  46. Bromage P. A comparison of the hydrochloride and carbon dioxide salts of lidocaine and prilocaine in epidural analgesia. Acta Anaesthesiol Scand 1965; 16: 55–69

    Article  CAS  Google Scholar 

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© 2000 Springer-Verlag London

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McLure, H., Yentis, S. (2000). Clinical trials: what should we assess?. In: Reynolds, F. (eds) Regional Analgesia in Obstetrics. Springer, London. https://doi.org/10.1007/978-1-4471-0435-3_14

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  • DOI: https://doi.org/10.1007/978-1-4471-0435-3_14

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-1142-9

  • Online ISBN: 978-1-4471-0435-3

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