Clinical trial NCT00354029: Effect of Perioperative i.v. Low-dose S(+) Ketamine
Official title: Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhoids
Pain
Keywords: hemorrhoids
hemorrhoidectomy
S (+) ketamine
pain
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2006-07-19
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.

Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.

Detailed description: The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects.

The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.

The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.

The study is including patients undergoing hemorrhoidectomy.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of disc prolapse
* Age 18+
* ASA (American Society in Anesthesiology) I-II
* written consent

Exclusion Criteria:

* Age \< 18
* ASA \> II
* liver failure
* renal failure
* heart failure
* glaucoma
* pregnancy

Primary outcomes:
measure: NRS Pain = Numeric Rating Scale (0-10)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Asker and Baerum Hospital
Study officials:
affiliation: Asker and Baerum Hospital, Norway
name: Ulrich J Spreng, Dr. med,
role: PRINCIPAL_INVESTIGATOR
affiliation: Asker and Baerum Hospital, Norway
name: Vegard Dahl, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Arendt-Nielsen L, Nielsen J, Petersen-Felix S, Schnider TW, Zbinden AM. Effect of racemic mixture and the (S+)-isomer of ketamine on temporal and spatial summation of pain. Br J Anaesth. 1996 Nov;77(5):625-31. doi: 10.1093/bja/77.5.625.
citation: Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available.
citation: Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x.