NCT07138053

The Impact Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

The Impact of Multimodal Balancing Anesthesia vs Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Cantonal Hospital Zenica · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This studi compared impact of multimodal balancing anesthesia vs opioid free anesthesia on postoperative pain intensity and stress response after open gynecology surgery. Hypothesis was: opioid free anesthesia reduces postoperative pain intensity and stress response in terms of the value for pain in VAS (Visual Analog Scala) and for stress response in value of cortisol, prolactin and IL-6, CRP and improves postoperative patients subjective well-being and surgical outcome.

Detailed description

This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Gynecology at the Cantonal Hospital Zenica, Bosnia and Herzegovina. After obtaining ethical committee approval 80 participants, scheduled for elective open gynecology surgery were included into study. Sample size was estimated using sample size calculator software and power analysis with 90% confidence interval and power of 80%. Statistical significance was considered as p\< 0,05. The calculation indicated 35 participants per group would be sufficient to detect a 50% difference for IL-6, cortisol, prolactin and CRP between the groups. Assuming dropout would lead to a total sample size of 80 participants. Before each participant agreed to the join the study, the purpose and procedures of the study were fully explained and informed and written consent was obtained from each participant. A preoperative anesthetic examination was conducted the day before surgery. The interventional group, opioid free anesthesia group(OFA group) and the control group, multimodal balancing anesthesia group (MBA group). Randomization was performed by computer generated randomization codes. The codes which indicated the treatment were held in sealed opaque envelopes. Nurse who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the gynecologist, nurses and staff involved in data collection. The participants of MBA group were undergone to the traditional concept of preoperative and intraoperative anesthesia management with opioid. The participants in the intervention group received opioid free anesthesia and didn't received opioid in peroperativ period. Assessment of clinical parameters started at 06:00 am on the day of surgery (basal value). Peripheral venous blood samples were collected to measure serum levels of glucose, cortisol, prolactin, C-reactive protein, blood count and differential blood count and IL-6, and 06.00 am on the first postoperative day. Six hours post-surgery peripheral venous blood samples were collected to measure serum levels of glucose, cortisol, prolactin, blood count and differential blood count. All patients underwent to opioid free anesthesia will be given TAP block ultrasound guided after intubation and before surgical incision. Consciousness and pain respond monitored by Entropy or CONX device. Analgesia for opioid free arm during surgery will bi provided with combination of medicament (Dexmedetomidine, Ketamine, 2%Lidocaine, Dexamethasone and Magnesium sulfate). Blood pressure and hart rate recorded : before intubation, on intubation, skin incision, before extubation and two hour after extubation. Assessment of subjective well-being was performed using a 10 cm horizontal Visual Analogue Scales for 1, 2, 4, 6-12 and 12-24 hours post-surgery. Pain at rest, pain with mobilization, thirst, hunger, mouth dryness, anxiety and weakness were evaluated. The patients were explained how to use the scale. Postoperative data included and the time to oral intake. The following data were recorded also: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, type of surgery.

Conditions

• Opioid Free Anesthesia
• Stress Response
• Postoperative Pain

Interventions

Type	Name	Description
OTHER	OFA group	OFA group Premedication with Midazolame and Paracetamol 30 minutes before surgery on ward, Dexamethasona and infusion of Dexmedetomidin and 2% Lidocaine 10 min before intubation( 50mcg Dexmedetomidin and 500mg 2% Lidocaine add up to 50ml normal saline) 1ml/10kg in 10 min after intubation 1ml/10kg/h discontinued after last surgical sutures. TAP bloc ultrasound guided performed after intubation. Ketamine given 60 sec before incision in doses 0.5 mg/kg, and after if it is necessary according to ER and qNOX. Provided value range between 40-60 during surgery.

Timeline

• Start date: 2025-07-17
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Bosnia and Herzegovina