Post Operative PainNCT06020196
The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery
A study testing surgical rectus sheath block and subdermal local anaesthetic infiltration in people with Post Operative Pain, run by Ahmed M Maged, MD at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- surgical rectus sheath block and subdermal local anaesthetic infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The Obstetrics and Gynecology department of Kasr Alainy University Hospital
Cairo, El Manial, 11562
About this study
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
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.
Read the 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.
- Conditions
- Post Operative Pain
- Being tested
- surgical rectus sheath block, subdermal local anaesthetic infiltration
- Keywords
- surgical rectus sheath block, sudermal infiltration of local anaesthesia, cesarean section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical rectus sheath blockProcedure or surgery
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)
subdermal local anaesthetic infiltrationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block group | Active comparator | The participants will receive bilateral surgical rectus sheath block Receives: Procedure: surgical rectus sheath block |
| Subdermal group | Active comparator | The participants will receive subdermal infiltration of local anaesthetics. Receives: Procedure: subdermal local anaesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 hours
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
Measured: 48 hours
Secondary outcomes (4)
time of start of lactation
the interval between skin closure and the time the patient first breastfeeds her newborn.
Measured: 24 hours
time of start of ambulation
the interval between skin closure and the time patient first ambulated.
Measured: 24 hours
length of post-operative hospital stay
the interval between skin closure and the time patient discharged from hospital.
Measured: 24 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed M Maged, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed M. Maged, Professor, Study chair, Professor of Obstetrics and Gynecology at Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020196
- Sponsor's protocol ID
- 71
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06020196
- Acronym / sponsor ID
- 71
- Conditions
- Post Operative Pain
- Keywords
- surgical rectus sheath block, sudermal infiltration of local anaesthesia, cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Ahmed M Maged, MDUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block group | Active comparator | Procedure: surgical rectus sheath blockThe participants will receive bilateral surgical rectus sheath block |
| Subdermal group | Active comparator | Procedure: subdermal local anaesthetic infiltrationThe participants will receive subdermal infiltration of local anaesthetics. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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],
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical rectus sheath blockLocal 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) | Procedure or surgery | Rectus sheath block group |
| subdermal local anaesthetic infiltrationAfter 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 | Procedure or surgery | Subdermal group |
Primary outcome
postoperative pain during rest
Time frame: 6 hours
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.
Time frame: 48 hours
assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic
4 secondary outcomes
time of start of lactation
Time frame: 24 hours
time of start of ambulation
Time frame: 24 hours
length of post-operative hospital stay
Time frame: 24 hours
development of of side effects or complications.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M. Maged, Professor study chair
Professor of Obstetrics and Gynecology at Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical rectus sheath block and subdermal local anaesthetic infiltration in people with Post Operative Pain, run by Ahmed M Maged, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salma A. Abdelhady, Resident (00201064328392, salma.abdelrahman@residents.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain during rest (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.