Observational study on the incidence of rebound pain after urological, gynecological / obstetric and orthopedic / trauma surgery under spinal anesthesia versus general anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027807

Enrollment

360

Registered

2022-01-18

Start date

2022-01-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R52.0

Interventions

Group 1: Spinal anesthesia (trauma surgery / orthopedic, gynecological / obstetric and urological interventions). All elective surgical patients will be informed about their anesthetic procedure in th

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Elective interventions in urology, gynecology / obstetrics and orthopedics / trauma surgery in general anesthesia or spinal anesthesia with expected moderate to severe postoperative pain - Patients older than 18 years - Ability to give consent and willingness to participate in the study - A written declaration of consent is available - Sufficient knowledge of German

Exclusion criteria

Exclusion criteria: - Patients <18 years of age or unable to give consent - Emergency interventions - Refusal to participate in the study - Pre-medication with opioids

Design outcomes

Primary

Measure	Time frame
Integrated pain scores (IPS) within the first 24 hours: pain level taking into account a possibly higher MEQ (morphine equivalents) requirement or a significantly increased pain level in one of the groups, as in Dai et al. described. The exact calculation of the IPS is based on the NRS and the MEQ and is statistically validated (Silverman, O'Connor et al. 1993, Dai, Silverman et al. 2013). The IPS is calculated from the deviation of the mean rank of the pain score + deviation of the mean rank of the morphine equivalents and results in a value between approximately -200% and + 200% for each study participant (Silverman, O'Connor et al. 1993, Dai, Silverman et al. 2013). The groups can be tested for significance using the Mann-Whitney test; the effect size can be expressed using the ratio of mean ranks or as Wilcoxon-Mann-Whitney odds (Dai, Silverman et al. 2013).	—

Measure

Time frame

Integrated pain scores (IPS) within the first 24 hours: pain level taking into account a possibly higher MEQ (morphine equivalents) requirement or a significantly increased pain level in one of the groups, as in Dai et al. described. The exact calculation of the IPS is based on the NRS and the MEQ and is statistically validated (Silverman, O'Connor et al. 1993, Dai, Silverman et al. 2013). The IPS is calculated from the deviation of the mean rank of the pain score + deviation of the mean rank of the morphine equivalents and results in a value between approximately -200% and + 200% for each study participant (Silverman, O'Connor et al. 1993, Dai, Silverman et al. 2013). The groups can be tested for significance using the Mann-Whitney test; the effect size can be expressed using the ratio of mean ranks or as Wilcoxon-Mann-Whitney odds (Dai, Silverman et al. 2013).

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Secondary

Measure	Time frame
- Morphine equivalent consumption (MEQ consumption in milligrams) assuming equianalgesia (comparable pain scores) within the first 24 hours - Pain intensity on NRS from 0-10 at rest and during exercise / movement every 3 hours within the first 24 hours (NRS-AUC), pain quality on NRS from 0-10) - MEQ PACU (recovery room) - Time to first analgesic request - Peak NRS pain score 0-24 hours, time of the peak NRS, number of patients reaching peak NRS 7 - If necessary, subgroup analysis in high-risk patients (IPS / PIOC from +100 to +200), severe pain and high morphine consumption) with regard to the occurrence of rebound pain ‘ - Pain Intensity Opioid Consumption (PIOC) as a longitudinal pain parameter - Opioid-related side-effects (Opioid-related Symptom Distress Scale, OR-SDS) 0-24 hours - Patient satisfaction (NRS, PPP-33, QoR-15), postoperative recovery (GSR) - Frequency of complications and ADRs (shivering, postoperative nausea / vomiting, post-puncture headache, transient neurological symptoms, POUR)	—

Measure

Time frame

- Morphine equivalent consumption (MEQ consumption in milligrams) assuming equianalgesia (comparable pain scores) within the first 24 hours - Pain intensity on NRS from 0-10 at rest and during exercise / movement every 3 hours within the first 24 hours (NRS-AUC), pain quality on NRS from 0-10) - MEQ PACU (recovery room) - Time to first analgesic request - Peak NRS pain score 0-24 hours, time of the peak NRS, number of patients reaching peak NRS 7 - If necessary, subgroup analysis in high-risk patients (IPS / PIOC from +100 to +200), severe pain and high morphine consumption) with regard to the occurrence of rebound pain ‘ - Pain Intensity Opioid Consumption (PIOC) as a longitudinal pain parameter - Opioid-related side-effects (Opioid-related Symptom Distress Scale, OR-SDS) 0-24 hours - Patient satisfaction (NRS, PPP-33, QoR-15), postoperative recovery (GSR) - Frequency of complications and ADRs (shivering, postoperative nausea / vomiting, post-puncture headache, transient neurological symptoms, POUR)

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Countries

Germany

Contacts

Public ContactChristian Volberg

Klinik für Anästhesie und IntensivmedizinUniversitätsklinikum Gießen und MarburgStandort Marburg

christian.volberg@med.uni-marburg.de064215864934

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026