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The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical rectus sheath block
subdermal local anaesthetic infiltration
Sponsored by
Ahmed M Maged, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring surgical rectus sheath block, sudermal infiltration of local anaesthesia, cesarean section

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women with singleton pregnancies. Gestational age 37 to 41 weeks. Surgical history: no history of previous surgeries or history of previous 1 cesarean section, Age: 20 -35 years old, American Society of Anesthesiologists physical status classifications II (healthy pregnancy or with mild systemic disease) [Amr E. Abouleish et. al. 2015], Scheduled for elective cesarean section BMI: 18.5 - 35 kg/m2. Exclusion Criteria: if they had American Society of Anaesthesiologists (ASA) status III and above (with severe systemic disease), Patients with BMI < 18.5 or > 35 kg/m2 were excluded as they require a different dosage of drug for spinal anesthesia, History of previous 2 Caesarian or more, Known allergy to the drug used (bupivacaine), Contraindication to NSAID: patients with suspected or manifest bleeding disturbances, allergy to NSAID, atopia, bronchial asthma, diabetes mellitus, those who previously had shown marked side effects after NSAID, the presence of liver or kidney disease, abuse of drugs or alcohol, excessive smokers and patients with pregnancy induced hypertension or pre-eclampsia Bleeding disorders, e.g.: thrombocytopenia, Neurological disorders associated with sensory alterations, e.g., Transverse myelitis can cause back pain, abnormal sensations in the trunk and genital region and legs such as sensory loss or paresthesias (abnormal sensations such as burning, tickling, pricking, numbness, coldness, or tingling). Rheumatological diseases e.g., primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), accompanied by chronic widespread pain due to arthralgia, myalgia or serositis. Requiring general anesthesia, if vertical abdominal incision was required, Local infection at the site of injection or The inability to provide a pain score, e.g., visual impairement.

Sites / Locations

  • The Obstetrics and Gynecology department of Kasr Alainy University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rectus sheath block group

Subdermal group

Arm Description

The participants will receive bilateral surgical rectus sheath block

The participants will receive subdermal infiltration of local anaesthetics.

Outcomes

Primary Outcome Measures

postoperative pain during rest
All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS)
the amount of additional analgesics consumption post-operatively for pain relief.
assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic

Secondary Outcome Measures

time of start of lactation
the interval between skin closure and the time the patient first breastfeeds her newborn.
time of start of ambulation
the interval between skin closure and the time patient first ambulated.
length of post-operative hospital stay
the interval between skin closure and the time patient discharged from hospital.
development of of side effects or complications.
The patient was observed for potential complications of RSB: The superior and inferior epigastric arteries are at risk of injury Visceral damage, Local anesthetic systemic toxicity, leading to seizures or ventricular arrhythmias (rare) Incomplete block may result from anatomical variance, as in up to 30% of the population. Failure of the block as the posterior wall of the rectus sheath lying superficial to the peritoneal cavity, needle misplacement may lead to injection into the peritoneal cavity. Infection. The patient was observed for potential complications of subdermal local anesthetic infilteration, including wound infection also the paients were observed for developemt of NSAID side effec

Full Information

First Posted
August 25, 2023
Last Updated
August 30, 2023
Sponsor
Ahmed M Maged, MD
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1. Study Identification

Unique Protocol Identification Number
NCT06020196
Brief Title
The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery
Official Title
The Safety and Efficacy of Surgical Rectus Sheath Block Compared to Subdermal Infiltration of Local Anaesthetic for Postoperative Analgesia After Elective Cesarean Section: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed M Maged, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
All participants will receive spinal anaesthesia and will be randomly divided into 2 equal groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to the rectus sheath space under direct vision before closure of the anterior abdominal wall. Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25% Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.
Detailed Description
All participants will receive spinal anaesthesia and will be randomly divided into 2 equal groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to the rectus sheath space under direct vision before closure of the anterior abdominal wall. Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25% Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine. All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS). Primary outcome parameters were VAS score during rest and the need for additional analgesics during the first 48 post-operative hours. Other parameters will be time of start of lactation and ambulation, length of post-operative hospital stay, and occurrence of side effects or complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
surgical rectus sheath block, sudermal infiltration of local anaesthesia, cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a prospective, single-blinded, randomized controlled trial (RCT) that include 182 patients scheduled for an elective lower segment Cesarean section at the Obstetrics and Gynecology department of Kasr Alainy University Hospital from April 2023 to August 2023. After obtaining approval from the hospital's institutional review board, we assessed 182 young women scheduled for an elective lower segment Cesarean section to determine their eligibility for the study. The182 patients admitted to be enrolled in our study, in which they're randomized into 2 groups, Group 1(n= 91) received bilateral surgical rectus sheath block and Group 2 (n =91) received subdermal infiltration of local anaesthetics.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectus sheath block group
Arm Type
Active Comparator
Arm Description
The participants will receive bilateral surgical rectus sheath block
Arm Title
Subdermal group
Arm Type
Active Comparator
Arm Description
The participants will receive subdermal infiltration of local anaesthetics.
Intervention Type
Procedure
Intervention Name(s)
surgical rectus sheath block
Intervention Description
Local anaesthetic will be administered into the rectus sheath space by the surgeon, towards the end of the operation, at the time of closure of the anterior abdominal wall (before the closure of peritoneum)
Intervention Type
Procedure
Intervention Name(s)
subdermal local anaesthetic infiltration
Intervention Description
After closure of the subcutaneous fat, the edges of the skin become more stable; subdermal Infiltration with moving needle technique was done to optimize distribution of the local anesthetic solution
Primary Outcome Measure Information:
Title
postoperative pain during rest
Description
All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS)
Time Frame
6 hours
Title
the amount of additional analgesics consumption post-operatively for pain relief.
Description
assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
time of start of lactation
Description
the interval between skin closure and the time the patient first breastfeeds her newborn.
Time Frame
24 hours
Title
time of start of ambulation
Description
the interval between skin closure and the time patient first ambulated.
Time Frame
24 hours
Title
length of post-operative hospital stay
Description
the interval between skin closure and the time patient discharged from hospital.
Time Frame
24 hours
Title
development of of side effects or complications.
Description
The patient was observed for potential complications of RSB: The superior and inferior epigastric arteries are at risk of injury Visceral damage, Local anesthetic systemic toxicity, leading to seizures or ventricular arrhythmias (rare) Incomplete block may result from anatomical variance, as in up to 30% of the population. Failure of the block as the posterior wall of the rectus sheath lying superficial to the peritoneal cavity, needle misplacement may lead to injection into the peritoneal cavity. Infection. The patient was observed for potential complications of subdermal local anesthetic infilteration, including wound infection also the paients were observed for developemt of NSAID side effec
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with singleton pregnancies. Gestational age 37 to 41 weeks. Surgical history: no history of previous surgeries or history of previous 1 cesarean section, Age: 20 -35 years old, American Society of Anesthesiologists physical status classifications II (healthy pregnancy or with mild systemic disease) [Amr E. Abouleish et. al. 2015], Scheduled for elective cesarean section BMI: 18.5 - 35 kg/m2. Exclusion Criteria: if they had American Society of Anaesthesiologists (ASA) status III and above (with severe systemic disease), Patients with BMI < 18.5 or > 35 kg/m2 were excluded as they require a different dosage of drug for spinal anesthesia, History of previous 2 Caesarian or more, Known allergy to the drug used (bupivacaine), Contraindication to NSAID: patients with suspected or manifest bleeding disturbances, allergy to NSAID, atopia, bronchial asthma, diabetes mellitus, those who previously had shown marked side effects after NSAID, the presence of liver or kidney disease, abuse of drugs or alcohol, excessive smokers and patients with pregnancy induced hypertension or pre-eclampsia Bleeding disorders, e.g.: thrombocytopenia, Neurological disorders associated with sensory alterations, e.g., Transverse myelitis can cause back pain, abnormal sensations in the trunk and genital region and legs such as sensory loss or paresthesias (abnormal sensations such as burning, tickling, pricking, numbness, coldness, or tingling). Rheumatological diseases e.g., primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), accompanied by chronic widespread pain due to arthralgia, myalgia or serositis. Requiring general anesthesia, if vertical abdominal incision was required, Local infection at the site of injection or The inability to provide a pain score, e.g., visual impairement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salma A. Abdelhady, Resident
Phone
00201064328392
Email
salma.abdelrahman@residents.kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A. Hamza, Lecturer
Phone
00201007100166
Email
dr.hamza.mh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M. Maged, Professor
Organizational Affiliation
Professor of Obstetrics and Gynecology at Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
The Obstetrics and Gynecology department of Kasr Alainy University Hospital
City
Cairo
State/Province
El Manial
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery

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