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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-17

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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

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Opioid Free Anesthesia Stress Response Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The diagnostic protocol was performed in patients at the gynecology department. The patients with diagnosed non cancer pathology and who needed gynecolog surgery were prepared for the surgical procedure. After that, patients were examined to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Surgeons and outcome assessors were masking to the treatment allocation. Masking was impossible for anesthetist because anesthetist was performed different tip of anesthesia during surgery.

The outcome study were evaluated by independent assessors who were also masked because they evaluated patients after surgery on a daily base during hospital stay without knowledge of the type intervention.

Study Groups

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MBA group

anesthesia based on opioids (multimodal balancing anesthesia with opioids)

Group Type NO_INTERVENTION

No interventions assigned to this group

OFA group

Experimental group will not receive opioids in perioperativ period

Group Type EXPERIMENTAL

OFA group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* aged between 18 years and 65 years
* participants scheduled for elective open gynecology surgery non cancer

Exclusion Criteria

body mass index above 30 kg/m2, diabetes mellitus, emergence surgery, cardiopulmonary disease, neuromusular disease, renal disease, vaginal hysterectomy, hepatic or endocrine disease, pregnancy, mental disease, allergy to any study drugs, alcoholic or drug abuse, ASA III and IV, patient's refusal to participate in the study, duration of surgery below 30min and over 90min.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No