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Effect of S-ketamine in Cesarean Section Combined Anesthesia

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

S-ketamine

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring S-ketamine, Cesarean Section, hyperalgesia

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

ASA status I-III
Age 20 to 45
37-42 weeks gestation
undergo elective cesarean section with subarachnoid anesthesia
participate in this study and sign informed consent

Exclusion Criteria:

Patients with contraindications for cesarean section
Patients with contraindications of combined spinal and epidural anesthesia
Patients with severe systemic disease
Alcoholism and long-term use of anti-inflammatory and analgesic drugs
Patients who were unable to cooperate or refused to participate in the trial
Patients with contraindications to esketamine and hydromorphone

Sites / Locations

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Group E1

Group E2

Group C1

Group C2

Arm Description

S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml

S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml

placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

Outcomes

Primary Outcome Measures

Maximum pain score (NRS socre) at 0-24 hours postoperatively

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Pain score (NRS socre) at 0-6 hours postoperatively

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Pain score (NRS socre) at 6-12 hours postoperatively

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Pain score (NRS socre) at 12-24 hours postoperatively

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Secondary Outcome Measures

The number of patient controlled analgesia pump pressed

When the patients felt pain, the patient controlled analgesia pump can be pressed once

Patient controlled analgesia pump analgesic consumption

The amount of the analgesic consumption

Pressure pain threshold at 30min after surgery

Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2

Pressure pain threshold at 24 hours after surgery

Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2

Pressure pain tolerance at 30min hours after surgery

Pressure pain tolerance was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2

Full Information

NCT ID

NCT05414006

First Posted

June 1, 2022

Last Updated

February 22, 2023

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05414006

Brief Title

Effect of S-ketamine in Cesarean Section Combined Anesthesia

Official Title

Effect of S-ketamine in Cesarean Section Combined Anesthesia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

June 14, 2022 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia. Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

S-ketamine, Cesarean Section, hyperalgesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group E1

Arm Type

Experimental

Arm Description

Arm Title

Group E2

Arm Type

Experimental

Arm Description

S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

Arm Title

Group C1

Arm Type

Placebo Comparator

Arm Description

Arm Title

Group C2

Arm Type

Placebo Comparator

Arm Description

placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

Intervention Type

Drug

Intervention Name(s)

S-ketamine

Other Intervention Name(s)

Patient controlled analgesia

Intervention Description

S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively

Primary Outcome Measure Information:

Title

Maximum pain score (NRS socre) at 0-24 hours postoperatively

Description

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Time Frame

From ending of the surgery to 24 hours postoperatively

Title

Pain score (NRS socre) at 0-6 hours postoperatively

Description

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Time Frame

From ending of the surgery to 6 hours postoperatively

Title

Pain score (NRS socre) at 6-12 hours postoperatively

Description

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Time Frame

From 6 hours postoperatively to 12 hours postoperatively

Title

Pain score (NRS socre) at 12-24 hours postoperatively

Description

NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

Time Frame

From 12 hours postoperatively to 24 hours postoperatively

Secondary Outcome Measure Information:

Title

The number of patient controlled analgesia pump pressed

Description

When the patients felt pain, the patient controlled analgesia pump can be pressed once

Time Frame

0-48 hours postoperatively

Title

Patient controlled analgesia pump analgesic consumption

Description

The amount of the analgesic consumption

Time Frame

0-48 hours postoperatively

Title

Pressure pain threshold at 30min after surgery

Description

Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2

Time Frame

Change from baseline to 30 minutes postoperatively

Title

Pressure pain threshold at 24 hours after surgery

Description

Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2

Time Frame

Change from baseline to 30 min postoperatively

Title

Pressure pain tolerance at 30min hours after surgery

Description

Pressure pain tolerance was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2

Time Frame

Change from baseline to 24 hours postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA status I-III Age 20 to 45 37-42 weeks gestation undergo elective cesarean section with subarachnoid anesthesia participate in this study and sign informed consent Exclusion Criteria: Patients with contraindications for cesarean section Patients with contraindications of combined spinal and epidural anesthesia Patients with severe systemic disease Alcoholism and long-term use of anti-inflammatory and analgesic drugs Patients who were unable to cooperate or refused to participate in the trial Patients with contraindications to esketamine and hydromorphone

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HUANG HE, MD

Organizational Affiliation

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400010

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The individual participant data for this study is available from the sponsor on reasonable request through email

IPD Sharing Time Frame

Within five years

Learn more about this trial

Effect of S-ketamine in Cesarean Section Combined Anesthesia

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