Clinical trial NCT06020196: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: surgical rectus sheath block
sudermal infiltration of local anaesthesia
cesarean section
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 182
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: postoperative pain during rest
timeFrame: 6 hours
measure: the amount of additional analgesics consumption post-operatively for pain relief.
timeFrame: 48 hours
Secondary outcomes:
measure: time of start of lactation
timeFrame: 24 hours
measure: time of start of ambulation
timeFrame: 24 hours
measure: length of post-operative hospital stay
timeFrame: 24 hours
measure: development of of side effects or complications.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Obstetrics and Gynecology department of Kasr Alainy University Hospital
state: El Manial
Study officials:
affiliation: Professor of Obstetrics and Gynecology at Cairo University
name: Ahmed M. Maged, Professor
role: STUDY_CHAIR
References: