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Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intrathecal morphine for intrathecal morphine group . bupivacaine 0.25% for Quadratus Lumborum and Erector Spinae nerve block groups .
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18-40 years old more or equal 37 weeks of gestation ASA 1,2 Elective cesarean delivery Exclusion Criteria: Patient refusal inability to cooperate with or understand the study local infection. bleeding disorder known anaphylaxis to any drug used in the trial ASA physical status more than 2 emergency operations chronic opioid use (opioid use in the past 3 months) Neurologic deficit or disorder contraindication to regional anesthesia.

Sites / Locations

  • Mahmoud Mamdouh EkramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intrathcal Morphine Group

Quadratus Lumborum nerve block group

Erector Spinae nerve block group

Arm Description

Intrathecal morphine administration for post operative pain relief after cesarean section

Quadratus Lumborum nerve block administration for post operative pain relief after cesarean section

Erector Spinae nerve block administraion for post operative pain relief after cesarean section

Outcomes

Primary Outcome Measures

Duration of analgesia until first analgesic request.
post operative pain control.

Secondary Outcome Measures

onset of pain . pain intensity using Numerical Analogue Score ( NRS) . ordered from 0 to 10 . 0 value indicates no pain , 10 value indicates worst pain
post operative pain control.

Full Information

First Posted
October 10, 2023
Last Updated
October 15, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT06088420
Brief Title
Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section
Official Title
Analgesic Efficacy of Erector Spinae Block , Quadratus Lumborum Block and Intrathecal Morphine for Post Operative Pain Relief After Cesarean Section, A Prospective Randomized Single-Blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
comparing analgesic efficacy of different nerve blocks on post operative cesarean sections.
Detailed Description
Analgesic efficacy of Erector Spinae, Quadratus Lumborum and Intrathecal Morphine for post operative pain relief after cesarean section, A Prospective Randomized Single-Blind Controlled Study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrathcal Morphine Group
Arm Type
Active Comparator
Arm Description
Intrathecal morphine administration for post operative pain relief after cesarean section
Arm Title
Quadratus Lumborum nerve block group
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum nerve block administration for post operative pain relief after cesarean section
Arm Title
Erector Spinae nerve block group
Arm Type
Active Comparator
Arm Description
Erector Spinae nerve block administraion for post operative pain relief after cesarean section
Intervention Type
Drug
Intervention Name(s)
intrathecal morphine for intrathecal morphine group . bupivacaine 0.25% for Quadratus Lumborum and Erector Spinae nerve block groups .
Intervention Description
Intrathecal morphine Group: All members of this group will receive spinal anesthesia with 12 mg 0.5% (2.2ml) hyperbaric bupivicane with intrathecal morphine(100mcg). QLB Group: All members of this group will receive bilateral quadratus lumborum block after spinal anesthesia at end of operation. The QLB will be performed by using bupivacaine 0.25% .ESB Group: All members of this group will receive bilateral erector spinae block after spinal anesthesia at end of operation. The ESB will be performed by using bupivacaine 0.25% (15 ml in each side) .
Primary Outcome Measure Information:
Title
Duration of analgesia until first analgesic request.
Description
post operative pain control.
Time Frame
24 hours .
Secondary Outcome Measure Information:
Title
onset of pain . pain intensity using Numerical Analogue Score ( NRS) . ordered from 0 to 10 . 0 value indicates no pain , 10 value indicates worst pain
Description
post operative pain control.
Time Frame
more or less than 2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
post operative pain relief after cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-40 years old more or equal 37 weeks of gestation ASA 1,2 Elective cesarean delivery Exclusion Criteria: Patient refusal inability to cooperate with or understand the study local infection. bleeding disorder known anaphylaxis to any drug used in the trial ASA physical status more than 2 emergency operations chronic opioid use (opioid use in the past 3 months) Neurologic deficit or disorder contraindication to regional anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dr. Hoha Hassan, lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Mahmoud Mamdouh Ekram
City
Assiut
State/Province
Manfalout
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr . Noha Hassan, Lecturer
Phone
01069009221
Email
nohadaghash@.gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section

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