A Phase 4 interventional study of spinal anesthesia with intrathecal morphine and TAP-block with ropivacaine and clonidine in Postoperative Pain, sponsored by Benno Rehberg-Klug. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Benno Rehberg-Klug · Phase 4, Interventional, and Treatment
Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common.
Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects.
With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine.
The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 180 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Benno Rehberg-Klug is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects must satisfy all of the following criteria to be enrolled into the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
spinal anesthesia with intrathecal morphine
Other: spinal anesthesia with intrathecal morphine
TAP-block with ropivacaine and clonidine
Other: TAP-block with ropivacaine and clonidine
in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added
cumulative incidence of nausea and/or vomiting at 24 hours
Data for this endpoint will be gathered at 6h and 24h postoperatively from nurses' records in the recovery room (at 6h) and on the ward (at 24h), and counterchecked by asking the patient
Time frame: 24 hours
Cumulative incidence of pruritus at 24h
inquired directly from the patient at 6 and 24h
Time frame: 24 h
Cumulative incidence of treated nausea and vomiting at 24h
(inquired directly from the patient at 6 and 24h).
Time frame: 24h
Cumulative incidence of sedation at 6 and 24h.
Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4
Time frame: 24h
Cumulative incidence of arterial hypotension
defined as a systolic blood pressure of less than 100 mmHg for longer than 5 minutes (from nurse records at 6 and 24h)
Time frame: 24h
Cumulative incidence of bradycardia
defined as a heart rate of less than 50/min for longer than 5 minutes (from nurse records at 6 and 24h)
Time frame: 24h
Cumulative incidence of respiratory depression
defined as a respiratory frequency of less than 8/min for longer than 5 minutes (from nurse records at 6 and 24h
Time frame: 24h
Cumulative morphine consumption at 24 hours
(recorded in the memory of the patient controlled analgesia (PCA) pump).
Time frame: 24h
Time until first PCA request
(recorded in the memory of the PCA pump
Time frame: 24h
Pain score at rest at 6, 24 and 48 hours postoperatively
using the NRS scale (0-10)
Time frame: 48h
Pain score on movement
at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).
Time frame: 48h
Maternal satisfaction at 24 and 48 hours postoperatively
measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h
Time frame: 48h
persistent pain at 3 and 6 months postoperatively
Pain at rest, 0-10 pain scale; Pain on movement, 0-10 pain scale; Yes/no for scar pain;Yes/no for analgesic use
Time frame: 6 months
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Benno Rehberg-Klug