Department of Obstetrics and Gynaecology, Queen Mary Hospital
Hong Kong
NCT Number: NCT02790099
Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 4
Hong Kong
The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.
Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.
Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.
On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.
Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.
Other names: Marcain
0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.
Time frame: at 12 hours postoperatively
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Time frame: within 24hours postoperatively
Paracetamol 1gram four times a day on request basis will be prescribed. The number of time requiring paracetamol will be recorded. The need of additional analgesics will be recorded.
Time frame: 3days postoperatively
time of starting mobilization, defined as able to get out of bed without assistance
Time frame: 3days postoperatively
side effects including itchiness, nausea/ vomiting, sedation
Time frame: Immediate postoperative
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10), will be accessed at the recovery room after the operation.
Time frame: 4hours postoperatively
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Time frame: 8hrs postoperatively
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Time frame: 24hrs postoperatively
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Queen Mary Hospital, Hong Kong
Other
Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details