An interventional study of Oksykodonhydroklorid and Ondansetron and Droperidol in Inguinal Hernia and Pain, Postoperative, sponsored by Ostfold Hospital Trust. Completed at 1 site in Norway. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Treatment
One of the most common complications after hernia repair is postoperative and chronic pain. TAP (transverse abdominis plain) block is a recommended multimodal method of reducing postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this study is to determine whether the use of a perioperative echo guided unilateral TAP block has a superior effect on postoperative pain after laparoscopic inguinal repair compared to an anterior Quadratus Lumborum Block with a long acting local anesthetic.
One of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return fully to normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open and laparoscopic inguinal hernia repair (Berndsen FH 2007) (Nienhuijs SW 2005).
TAP (transverse abdominis plain) block is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery (El-Dawlatly AA 2009; 102). TAP block (Meyer A 2015) and an anterior Quadratus Lumborum Block (Adhikary, S.D. 2017) are both recommended for inguinal hernia repair. The objective of this study is to determine, whether the use of a perioperative echo guided unilateral TAP block has a superior effect on postoperative pain after laparoscopic inguinal repair compared to the anterior Quadratus Lumborum Block with a long acting local anesthetic. There will be no further analysis in this study regarding the evidence of open hernia inguinal repair and chronic pain.
The primary endpoint:
Opioid consumption measured in orale morphine equivalents four hours postoperative.
The secondary endpoints:
Opoioid consumption measured in orale morphine equivalents after 24 hours, 48 hours and seven days postoperative.
Postoperative nausea and vomiting measured on a NRS scale 0-3 at timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days. Sedation scores measured on a NRS scale 0-3 at timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days. .
There will be conducted a telephone interview by a blinded study nurse at 24 h, 48 h and 7 days, interviewing the patients as to their NRS score, nausea, sedation, level of activity and satisfaction with their overall treatment.
Power and Sample Size Calculator A pilot consisting of 12 patients was performed. The patients recieved a TAP block before a elective laparoscopic inguinal hernia repair. The mean oral morphine equivalents after four hours postoperative was 8.75 mg and the standard deviation 5.93 mg. With a significant clinical difference of 50%,an α = 0,05 and an effect size of 80% (β = 0,2) the total sample size is 60 patients with 30 patients in each group.
Premedication: Paracetamol by weight (2 grams (g)>70 kilos (kg) \<70 years, 1,5 g \<70 kg >70 years, 1 g \<50 kg) , Diclofenac by weight (100 milligrams (mg) >70 kg \<70 years, 50 mg \<70 kg >70 years).
General anaesthesia: TCI (Target Control Infusion = Anesthesia protocol): Propofol and Remifentanil Surgical procedure: Laparoscopic inguinal hernia repair. 5 mg/ml 10 ml Ropivacaine in the ports peroperatively.
Postoperatively:
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Ostfold Hospital Trust is the lead sponsor of 48 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
A single shot unilateral transmuscular Quadratus lumborum Block with Ropivacaine 7,5 mg/ml, 20 ml
Drug: Oksykodonhydroklorid · Drug: Ondansetron and Droperidol · Drug: Ropivacaine
A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml
Drug: Oksykodonhydroklorid · Drug: Ondansetron and Droperidol · Drug: Ropivacaine
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Also known as: oxycodone
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Also known as: Ondansetron and Dridol
Local anesthetic for the block
Opioid consumption measured as orale morphine equivalents.
Differences in opioid consumption after four hours.
Time frame: 0 - 4 hours
Postoperative nausea and vomiting
Nausea is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
Time frame: 0 - 7 days postoperative.
Sedation scores
Sedation is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
Time frame: 0 - 7 days postoperative.
Opioid consumption measured in orale morphine equivalents.
Opioid consumption measured at 24 hours, 48 hours and seven days.
Time frame: 4 hours- 7 days postopertive.
Plan to share: Undecided — No sharing plan so far
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Ostfold Hospital Trust