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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020196
• Other study ID #: 71
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: April 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Salma A. Abdelhady, Resident
• Phone: 00201064328392
• Email: salma.abdelrahman[@]residents.kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 182
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• surgical rectus sheath block
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 infiltration
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

Locations

Country	Name	City	State
Egypt	The Obstetrics and Gynecology department of Kasr Alainy University Hospital	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed M Maged, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 hours
Primary	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	48 hours
Secondary	time of start of lactation	the interval between skin closure and the time the patient first breastfeeds her newborn.	24 hours
Secondary	time of start of ambulation	the interval between skin closure and the time patient first ambulated.	24 hours
Secondary	length of post-operative hospital stay	the interval between skin closure and the time patient discharged from hospital.	24 hours
Secondary	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	24 hours