Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery
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ClinicalTrials.gov Identifier: NCT01760161 |
Recruitment Status :
Terminated
(No signal on pain-score)
First Posted : January 4, 2013
Last Update Posted : May 12, 2015
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Condition or disease | Intervention/treatment | Phase |
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Pain Treatment Robotic Assisted Laparoscopic Surgery Bilateral Dual Transversus Abdominis Plane Block | Drug: Ropivacaine Drug: Isotonic potassium chloride | Not Applicable |
After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.
The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.
Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.
The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery |
Study Start Date : | April 2014 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ropivacain
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
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Drug: Ropivacaine
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block |
Placebo Comparator: Isotonic potassium chloride
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
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Drug: Isotonic potassium chloride
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block. |
- Pain-score on numerical rating scale [ Time Frame: 4 hours after surgery ]
- Administration of opioids [ Time Frame: The first 24 hours after surgery. ]
- Pain-score on numerical rating scale [ Time Frame: 8 hours after surgery ]
- Pain-score on numerical rating scale [ Time Frame: 24 hours after surgery ]
- Thermoanalgesia at dermatome-level th6-th12 [ Time Frame: 1 hour after bilateral dual transversus abdominis plane block ]
- Plasma-ropivacain level [ Time Frame: 15, 30, 60, 120 and 240 mins after the block ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients scheduled for robotic assisted laparoscopis surgery
- acceptance to participate
Exclusion Criteria:
- allergies to local analgetics
- daily use of strong opioids

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760161
Denmark | |
Aalborg Hospital | |
Aalborg, Region Nord, Denmark, 9000 |
Responsible Party: | Nils Bjerregaard, Consultant Anestetist, Aalborg University Hospital |
ClinicalTrials.gov Identifier: | NCT01760161 |
Other Study ID Numbers: |
20120042 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | May 12, 2015 |
Last Verified: | May 2015 |
postoperative pain opioid consumption termanalgesia plasmaropivacain level |
Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |