Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Spinal Bupivacaine/Morphine in Laparoscopic Surgery Clinical Trial

— Salmon  

Official title:

Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284282
• Other study ID #: NL43488.101.13
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Description:

We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal with bupicavaine/morphine will result in a better analgesia in hte first 48 hours. Herby the patients will require less systemic opioids, which will decrease the side-effects. Furthermore, we expect the patients to recover quicker and show an earlier mobilisation and a shorter hospital stay.

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Laparoscopic Gastro-intestinal surgery

Exclusion Criteria:

• Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery

Related Conditions & MeSH terms

• Spinal Bupivacaine/Morphine in Laparoscopic Surgery

Intervention

Drug:
• Spinal injection bupivacaine/morphine
Spinal injection bupivacaine/morphine in laparoscopic surgery
• subcutaneum injection lidocaine
placebo injection

Locations

Country	Name	City	State
Netherlands	Maasstad Hospital	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Koning MV, Teunissen AJW, van der Harst E, Ruijgrok EJ, Stolker RJ. Intrathecal Morphine for Laparoscopic Segmental Colonic Resection as Part of an Enhanced Recovery Protocol: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):166-173. doi: 10.1097/AAP.0000000000000703. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospital stay		first 48 hours
Secondary	use of piritramide by PCIA-pump in mg		48 hours
Secondary	patient-satisfactory on a 4-point scale		120 hours/ 5 days
Secondary	the occurence of side-effects (nausea, pruritus, drowsiness)		120 hours/ 5 days
Secondary	time to mobilisation		120 hours/ 5 days
Secondary	time to bowel movement		120 hours/ 5 days
Secondary	abdominal compliance during laparoscopy in L/mmHg		The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
Secondary	Difficulty of surgery		The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours

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