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Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine

Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02790099
Enrollment
144
Registered
2016-06-03
Start date
2014-09-30
Completion date
2016-06-30
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, Postoperative pain control, Rectus sheath block, Intrathecal morphine, Caesarean section

Brief summary

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.

Detailed description

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.

Interventions

DRUGBupivacaine

Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.

DRUGMorphine

0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.

Sponsors

Queen Mary Hospital, Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Planned for elective lower segment Caesarean section, using suprapubic transverse incision * Willing and able to participate after the study has been explained * Those understand either Cantonese, Putonghua or English

Exclusion criteria

* Patient with treatment for chronic pain * History of narcotic abuse/ recreational drug use * Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs * Patient with pre-eclampsia

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreat 12 hours postoperativelyPain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

Secondary

MeasureTime frameDescription
Requirement of oral analgesicswithin 24hours postoperativelyParacetamol 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 of mobilization3days postoperativelytime of starting mobilization, defined as able to get out of bed without assistance
Side effect3days postoperativelyside effects including itchiness, nausea/ vomiting, sedation
Pain scoreImmediate postoperativePain 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026